Device and method for reinforcement of a facet

ABSTRACT

In some embodiments, a device for reinforcement of a facet joint is provided. The device comprises a lumen configured to receive a fastener member. In some embodiments, a second segment comprises a second lumen configured to receive a fastener member or fastener. In some embodiments, kits are provided with a fastener member and a facet reinforcement device. Methods are also provided for treating a spine. In some embodiments, the fastener member is placed through both articular processes of a facet joint and a facet reinforcement device.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 15/804,112 filed Nov. 6, 2017, which is a divisionalapplication of U.S. patent application Ser. No. 14/274,575 filed May 9,2014, which claims priority benefit under 35 U.S.C. § 119(e) of U.S.Provisional Patent Application No. 61/883,960, filed Sep. 27, 2013, theentirety of each is hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

Some embodiments described herein relate generally to methods andimplants for fusing bone, for example, fusing vertebrae by securing thearticular processes of the vertebrae.

Traumatic, inflammatory, and degenerative disorders of the spine canlead to severe pain and loss of mobility. One source of back and spinepain is related to degeneration of the facets of the spine or facetarthritis. Bony contact or grinding of degenerated facet joint surfacescan play a role in some pain syndromes. While many technologicaladvances have focused on the intervertebral disc and artificialreplacement or repair of the intervertebral disc, little advancement infacet repair has been made. Facet joint and disc degeneration frequentlyoccur together. Thus, a need exists to address the clinical concernsraised by degenerative facet joints.

The current standard of care to address the degenerative problems withthe facet joints is to fuse the two adjacent vertebrae. By performingthis surgical procedure, the relative motion between the two adjacentvertebrae is stopped, thus stopping motion of the facets and anypotential pain generated as a result thereof. Procedures to fuse twoadjacent vertebrae often involve fixation and/or stabilization of thetwo adjacent vertebrae until the two adjacent vertebrae fuse.

Injuries and/or surgical procedure on and/or effecting other bones canalso result in the desire to fixate and/or stabilize a bone until thebone, or bone portions, can fuse, for example, to stabilize a sternumafter heart surgery, to stabilize a rib after a break, etc. Currentprocedures to fixate and/or stabilize adjacent vertebrae and/or otherbones can be slow and/or complex

Accordingly, a need exists for an apparatus and a procedure to quicklyand/or easily stabilize and/or fixate a bone.

SUMMARY OF THE INVENTION

In some embodiments, a device for reinforcing a facet joint implant isprovided. The device comprises a first securing segment comprising aproximal surface and a distal surface. The first securing segmentcomprises a first lumen disposed between the proximal surface and thedistal surface. The first lumen is adapted for receiving a fastenermember. The device comprises a second securing segment comprising aproximal surface and a distal surface. The second securing segmentcomprises a second lumen. The device comprises a central portion betweenthe first securing segment and the second securing segment.

In some embodiments a longitudinal axis of the first securing segment isdisposed at an angle relative to a longitudinal axis of the secondsecuring segment. In some embodiments, a plane of the distal surface ofthe first securing segment is not parallel to a plane of the distalsurface of the second securing segment. In some embodiments, the distalsurface of the facet reinforcement device is configured for engaging abony surface of a facet. In some embodiments, the distal surface of thefacet reinforcement device comprises sharp engagement members.

In some embodiments, a kit for treating a spine is provided. The kitcomprises a fastener member. The kit comprises a facet reinforcementdevice. The facet reinforcement device comprises a proximal surface anda distal surface. The facet reinforcement device comprises a lumendisposed between the proximal surface and the distal surface. The lumenis adapted for receiving the fastener member.

In some embodiments, the facet reinforcement device further comprises asecond portion adapted to attach to a spinous process of a vertebra. Inembodiments, the second portion of the facet reinforcement devicecomprises at least one lumen. Some embodiments of the kit, furthercomprise a fastener for securing the facet reinforcement device to thevertebra. In some embodiments, the fastener secures the facetreinforcement device to the spinous process of the superior vertebra. Insome embodiments, the fastener is a screw or bolt.

In some embodiments, a method for treating a spine is provided. Themethod may include placing a facet reinforcement device comprising alumen adjacent to a first vertebra. The method may include passing afastener member through the lumen. The method includes passing thefastener member through a first articular process of a facet joint. Themethod may include passing the fastener member through a secondarticular process of the facet joint. The method may include securingone end of the fastener member to the other end of the fastener member,thereby retaining the facet reinforcement device.

In some embodiments, a method for treating a spine is provided. Themethod may include the step of preparing a facet joint for fixation. Themethod may include passing a fastener member through a first articularprocess of a facet joint. The method may include passing a fastenermember through a second articular process of the facet joint. The methodmay include placing a facet reinforcement device with a lumen forreceiving the flexible fastening band against a surface of the firstarticular process. The method may include passing a fastener memberthrough the lumen. The method may include securing the fastener member.The method may include securing the facet reinforcement device to aspinous process with a fastener. The methods may further compriseinserting a facet implant with an interface configured to receive thefastener member into the facet joint. The methods may further comprisepassing the fastener member through the interface of the facet implant.

In some embodiments, a method for treating a spine is provided. Methodsmay further comprise preparing a second facet joint at a same level ofthe spine for fixation. The method may include placing a second facetreinforcement device against a first articular process of the secondfacet joint. The method may include passing a second fastener memberthrough a first articular process of the second facet joint. The methodmay include passing a second fastener member through a second articularprocess of the second facet joint. The method may include securing thesecond fastener member. The method may include securing the second facetreinforcement device to a spinous process with a fastener. The methodsmay further comprise inserting a second facet implant with an interfaceconfigured to receive the fastener member into the facet joint. Themethods may further comprise passing the second fastener member throughthe interface of the second facet implant.

In some embodiments, a device for placement on a facet joint isprovided, the purpose of the device being to provide reinforcement tothe bone when a fastener member is used to secure the joint. The devicemay include sharp engagement members on a bone contact side to preventmigration. The device may include a through-opening to accept a primaryfacet fixation device. In some embodiments, the device for placement ona facet joint has a second through-opening for accepting at least oneadditional fastener. In some embodiments, a screw may be provided forplacement through the second through-opening.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a lateral elevational view of a portion of the vertebralcolumn.

FIG. 2A is a schematic superior view of an isolated thoracic vertebra.

FIG. 2B are schematic side view of an isolated thoracic vertebra.

FIG. 3A is a schematic posterior elevational view of a portion of thevertebral column.

FIG. 3B is a posterior-oblique elevational view of a portion of thevertebral column.

FIG. 4A is a schematic side view of a facet joint in the cervicalvertebrae.

FIG. 4B is a schematic superior view of a facet joint in the cervicalvertebrae.

FIG. 5A is a schematic side view of a facet joint in the thoracicvertebrae.

FIG. 5B is a schematic superior view of a facet joint in the thoracicvertebrae.

FIG. 6A is a schematic side view of a facet joint in the lumbarvertebrae.

FIG. 6B is a schematic superior view of a facet joint in the lumbarvertebrae.

FIG. 7 is a block diagram of an implant according to an embodiment.

FIGS. 8A and 8B are schematic views of one embodiment of a facet jointimplant comprising a circular disc.

FIG. 8C is a schematic view of the implant from FIG. 7A implanted in afacet joint.

FIGS. 9A and 9B are schematic views of one embodiment of a facet jointimplant comprising an octagonal disc.

FIGS. 10A and 10B are schematic views of one embodiment of a facet jointimplant comprising a biconcave disc.

FIGS. 11A and 11B are schematic views of one embodiment of a facet jointimplant comprising a single-face variable thickness disc.

FIGS. 12A and 12B are schematic views of one embodiment of a facet jointimplant comprising a curved disc.

FIG. 13 is a schematic view of the implant from FIG. 12A implanted in afacet joint.

FIGS. 14A and 14B are schematic views of one embodiment of a facet jointimplant comprising a disc with a roughened surface on one face.

FIGS. 15A and 15B are schematic views of one embodiment of a facet jointimplant comprising a disc with a porous surface on one face.

FIGS. 16A and 16B are schematic views of one embodiment of a facet jointimplant comprising a bent disc with a roughened surface on the greaterface.

FIG. 17 is a schematic view of the implant from FIG. 16A implanted in afacet joint.

FIGS. 18A and 18B are schematic views of one embodiment of a facet jointimplant comprising two discs, each with a roughened surface on one face.

FIG. 19 is a schematic view of the implant from FIG. 18A implanted in afacet joint.

FIG. 20 is a schematic view of a fastener member comprising a braidedcable.

FIGS. 21A and 21B are schematic views of one embodiment of a facet jointimplant with a fastener interface comprising a centrally located hole.

FIGS. 22A and 22B are schematic views of one embodiment of a facet jointimplant with a fastener interface comprising an eccentrically locatedhole.

FIGS. 23A and 23B are schematic views of one embodiment of a facet jointimplant with a fastener interface comprising an edge contiguous hole.

FIGS. 24A and 24B are schematic views of one embodiment of a facet jointimplant comprising two discs, each with an eccentrically located hole.

FIGS. 25A and 25B are schematic views of one embodiment of a facet jointimplant comprising a curved disc with a fastener interface.

FIG. 26 depicts one embodiment where the cable is engaged to thearticular processes using knots in the cable.

FIGS. 27A and 27B depict another embodiment of the fastener membercomprising a braided cable with threaded ends adapted to accept threadednuts.

FIG. 28 depicts one embodiment where a cable is engaged to the articularprocesses using nuts threaded onto the cable.

FIG. 29 depicts a preferred embodiment comprising a curved implant,cable and two set-screw fastener rings.

FIGS. 30A and 30B are elevational and cross-sectional views of oneembodiment of the set-screw fastener rings, respectively.

FIGS. 31 through 33 are elevational views of various embodiments of thescrew in the set-screw fastener rings.

FIGS. 34A to 35B are one embodiment comprising friction fit fastenerrings. FIGS. 34A and 34B depict the fastener rings in their reducedstate and FIGS. 35A and 35B depict the fastener rings in their expandedstate.

FIGS. 36A to 36C illustrate embodiments comprising a implant with aclose-ended threaded fastener interface and a threaded fastener member.

FIGS. 36B and 36C depict a threaded fastener member with a pivotablewasher.

FIG. 37A is a cross sectional view of the implant in FIG. 36A implantedin a facet joint; FIG. 37B is a cross sectional view of the implant inFIG. 36B implanted in a facet joint.

FIG. 38 is a cross sectional view of a two-part implant comprising flatdiscs implanted into a facet joint.

FIG. 39 is a cross sectional view of a two-part implant comprisingcurved discs implanted into a facet joint.

FIGS. 40A and 40B are schematic views of one embodiment of a facet jointimplant with an integral fastener member comprising a centrally locatedbarbed spike.

FIGS. 41A and 41B are schematic views of one embodiment of a facet jointimplant with an integral fastener member comprising an eccentricallylocated barbed spike.

FIG. 42 depicts the implant of FIG. 41A implanted into a facet joint.

FIG. 43 illustrates a two-part implant implanted into a facet joint.

FIG. 44 shows one embodiment comprising a implant with multipleanchoring projections.

FIG. 45 shows the implant of FIG. 44 implanted into a facet joint.

FIGS. 46A and 46B depict one embodiment comprising a implant with arigid soft tissue side anchor.

FIGS. 47A and 47B depict one embodiment comprising a implant with anembedded flexible soft tissue side anchor.

FIG. 48A is a perspective view of an implant according to an embodiment.

FIG. 48B is a side view of the implant of FIG. 48A.

FIG. 48C is a cross-sectional side view of the implant of FIG. 48A.

FIGS. 49-51 are posterior perspective views of a portion of thevertebral column depicting a method of stabilizing a vertebra using animplant and fastener member according to an embodiment.

FIG. 52 is a flow chart illustrating a method of using the implant andfastener member depicted FIGS. 49-51.

FIG. 53 is a perspective view of a flexible fastening band according toan embodiment.

FIG. 54 is a perspective view of a portion of the flexible fasteningband depicted in FIG. 53.

FIG. 55 is a side view of a flexible fastening band according to anembodiment.

FIG. 56 is a top view the flexible fastening band depicted in FIG. 55.

FIG. 57 is a side view of a flexible fastening band according to anembodiment.

FIG. 58 is a perspective view of a flexible fastening band according toan embodiment.

FIG. 59 is a cross-sectional side view of the flexible fastening banddepicted in FIG. 58.

FIG. 60 is a cross-sectional view taken along line XXIII of the flexiblefastening band depicted in FIG. 58.

FIG. 61 is a cross-sectional top view of the flexible fastening banddepicted in FIG. 58 in a first configuration.

FIG. 62 is a cross-sectional top view of the flexible fastening banddepicted in FIG. 58 in a second configuration.

FIG. 63 is an exploded view of a flexible fastening band according to anembodiment.

FIG. 64 is a perspective view of the flexible fastening band depicted inFIG. 63.

FIG. 65 is a cross-sectional view of the flexible fastening banddepicted in FIG. 64.

FIG. 66 is a front perspective view of implant according to anembodiment.

FIG. 67 is a rear perspective view of the implant of FIG. 66.

FIG. 68 is a side view of the implant of FIG. 66.

FIG. 69 is a cross-sectional side view of the implant of FIG. 66.

FIG. 70 is a front perspective view of implant according to anembodiment.

FIG. 71 is a rear perspective view of the implant of FIG. 70.

FIG. 72 is a side view of the implant of FIG. 70.

FIG. 73 is a cross-sectional side view of the implant of FIG. 70.

FIG. 74 is a front perspective view of implant according to anembodiment.

FIG. 75 is a rear perspective view of the implant of FIG. 74.

FIG. 76 is a side view of the implant of FIG. 74.

FIG. 77 is a cross-sectional side view of the implant of FIG. 74.

FIG. 78 is a front perspective view of implant according to anembodiment.

FIG. 79 is a rear perspective view of the implant of FIG. 78.

FIG. 80 is a side view of the implant of FIG. 78.

FIG. 81 is a cross-sectional side view of the implant of FIG. 78.

FIG. 82 is a front perspective view of a facet reinforcement deviceaccording to an embodiment.

FIGS. 83-84 are posterior perspective views of a portion of thevertebral column depicting a method of stabilizing a vertebra using thefacet reinforcement device of FIG. 82 and a fastener member according toan embodiment.

FIG. 85 is a front perspective view of a facet reinforcement deviceaccording to an embodiment.

FIGS. 86-87 are posterior perspective views of a portion of thevertebral column depicting a method of stabilizing a vertebra using thefacet reinforcement device of FIG. 85 and a fastener member according toan embodiment.

FIG. 88 is a front perspective view of a facet reinforcement deviceaccording to an embodiment.

FIGS. 89-91 are perspective views of a portion of the vertebral columndepicting a method of stabilizing a vertebra using a first facetreinforcement device of FIG. 88, a second facet reinforcement device,and one or more fastener members according to an embodiment.

DETAILED DESCRIPTION

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a ratchet” is intended to mean a singleratchet or a combination of ratchets. As used in this specification, asubstance can include any biologic and/or chemical substance, including,but not limited to, medicine, adhesives, etc, and/or a bone graft,including, but not limited to, autograft, allograft, xenograft,alloplastic graft, a synthetic graft, and/or combinations of grafts,medicines, and/or adhesives. While exemplary references are made withrespect to vertebra, in some embodiments another bone can be involved.While specific reference may be made to a specific vertebra and/orsubset and/or grouping of vertebrae, it is understood that any vertebraand/or subset and/or grouping, or combination of vertebrae can be used.

As shown in FIG. 1, the vertebral column 2 comprises a series ofalternating vertebrae 4 and fibrous discs 6 that provide axial supportand movement to the upper portions of the body. The vertebral column 2typically comprises thirty-three vertebrae 4, with seven cervical(C1-C7), twelve thoracic (T1-T12), five lumbar (L1-15), five fusedsacral (S1-S5) and four fused coccygeal vertebrae. FIGS. 2A and 2Bdepict a typical thoracic vertebra. Each vertebra includes an anteriorbody 8 with a posterior arch 10. The posterior arch 10 comprises twopedicles 12 and two laminae 14 that join posteriorly to form a spinousprocess 16. Projecting from each side of the posterior arch 10 is atransverse 18, superior 20 and inferior articular process 22. The facets24, 26 of the superior 20 and inferior articular processes 22 form facetjoints 28 with the articular processes of the adjacent vertebrae (seeFIGS. 3A and 3B). The facet joints are true synovial joints withcartilaginous surfaces and a joint capsule.

The orientation of the facet joints vary, depending on the level of thevertebral column. In the C1 and C2 vertebrae, for example the facetjoints are parallel to the transverse plane. FIGS. 4A to 6B depictexamples of the orientations of the facet joints at different levels ofthe vertebral column. In the C3 to C7 vertebrae examples shown in FIGS.4A and 4B, the facets are oriented at a 45-degree angle to thetransverse plane 30 and parallel to the frontal plane 32, respectively.This orientation allows the facet joints of the cervical vertebrae toflex, extend, lateral flex and rotate. At a 45-degree angle in thetransverse plane 30, the facet joints of the cervical spine can guide,but do not limit, the movement of the cervical vertebrae. FIGS. 5A and5B depict examples of the thoracic vertebrae, where the facets areoriented at a 60-degree angle to the transverse plane 30 and a 20-degreeangle to the frontal plane 32, respectively. This orientation is capableof providing lateral flexion and rotation, but only limited flexion andextension. FIGS. 6A and 6B illustrate examples of the lumbar region,where the facet joints are oriented at 90-degree angles to thetransverse plane 30 and a 45-degree angle to the frontal plane 32,respectively. The lumbar vertebrae are capable of flexion, extension andlateral flexion, but little, if any, rotation because of the 90-degreeorientation of the facet joints in the transverse plane. The actualrange of motion along the vertebral column can vary considerably witheach individual vertebra.

In addition to guiding movement of the vertebrae, the facet joints alsocontribute to the load-bearing ability of the vertebral column. Onestudy by King et al. Mechanism of Spinal Injury Due to CaudocephaladAcceleration, Orthop. Clin. North Am., 6:19 1975, found facet jointload-bearing as high as 30% in some positions of the vertebral column.The facet joints may also play a role in resisting shear stressesbetween the vertebrae. Over time, these forces acting on the facetjoints can cause degeneration and arthritis.

In some embodiments described herein, a vertebral facet joint implantcan be used to stabilize, fixate, and/or fuse a first vertebra to asecond vertebra to reduce pain, to reduce further degradation of aspine, or of a specific vertebra of a spine, and/or until the firstvertebra and the second vertebra have fused. In some embodiments, thevertebral facet joint implant can be implanted and deployed to restorethe space between facets of a superior articular process of a firstvertebra and an inferior articular process of an adjacent vertebra. Insome embodiments, the vertebral facet joint implant can be implanted anddeployed to help stabilize adjacent vertebrae with adhesives, and/or canbe implanted and deployed to deliver a medication. FIG. 7 depicts ablock diagram of a vertebral facet joint implant (“implant”) 160.Implant 160 includes a first side 162, a second side 164, a fastenerinterface 166, and a substance interface 168. FIGS. 8A-47B depictimplants and fasteners according to different embodiments.

As shown in FIG. 7, implant 160 can be, for example, substantially discshaped. In other embodiments, the spacer can be other shapes, e.g.,square, elliptical, or any other shape. First side 162 and/or secondside 164 can be, for example, convex, concave, or flat. Said anotherway, first side 162 can be concave, convex, or flat, and second side 164can be concave, convex, or flat; for example, first side 162 can beconcave and second side 164 can be concave, first side 162 can beconcave and second side 164 can be convex, etc. In such embodiments, theshape can be determined based on a shape of a bone portion that thefirst side 162 and/or the second side 164 is configured to contact. Saidanother way, the first side 162 and/or the second side 164 can be shapedto substantially compliment the shape of a bone portion. On other words,the first side 162 or the second side 164 need not exactly match theshape of the corresponding bone portion, but instead can have a concaveshape for a bone portion with a generally convex shape where the contactwith the implant is to occur or can have a convex shape for a boneportion with a generally concave shape where the contact with theimplant is to occur. Implant 160 can include any biocompatible material,e.g., stainless steel, titanium, PEEK, nylon, etc.

Implant 160 includes fastener interface 166. Fastener interface 166 canbe configured to retain implant 160 in substantially the same position.Specifically, fastener interface 166 can be configured to accept afastener member (not shown) to substantially prevent movement of implant160. Fastener interface 166 can include an aperture and/or otheropening. Fastener interface 166 can extend through implant 160, e.g. canextend from first side 162 and through to second side 164. In someembodiments, fastener interface 166 can extend through only a portion ofimplant 160, e.g. can extend from first side 162 and through less thanhalf of a width (not shown) of implant 160. Fastener interface 166 canbe disposed on and/or through first side 162, second side 164, and/orboth first side 162 and second side 164. Fastener interface 166 can bedisposed through a center (not shown) of implant 160. In otherembodiments, fastener interface 166 can be disposed anywhere on and/orthrough implant 160, e.g., offset from center. Fastener interface 166can be substantially circular (cylindrical). In other embodiments,fastener interface 166 can be other shapes and/or can be shaped based ona shape of the fastener member, for example, rectangular (cuboid). Insome embodiments, fastener interface 166 can be a irregular shape, basedat least in part in the location of fastener interface 166, see, e.g.,FIG. 48, and/or partial shapes, see, e.g., FIG. 23B. Fastener interface166 can include a substantially smooth inner surface (not shown) toallow the fastener member to easily pass through and/or into fastenerinterface 166, and/or can include a threaded inner surface to allow thefastener member to thread into fastener interface 166. While depicted inFIG. 7 as including one fastener interface, implant 160 can include morethan one fastener interface 160.

Implant 160 includes substance interface 168. Substance interface can beconfigured to retain, carry and/or otherwise deliver a substance to aidin fusion, such as, for example, medicines, adhesives, bone graft,and/or combinations of substances. Substance interface 168 can includean aperture and/or other opening. Substance interface 168 can extendthrough implant 160, e.g. can extend from first side 162 and through tosecond side 164. In some embodiments, fastener interface can extendthrough only a portion of implant 160, e.g. can extend from first side162 and through less than half of a width (not shown) of implant 160.Substance interface 168 can be disposed on and/or through first side162, second side 164, and/or both first side 162 and second side 164.Substance interface 168 can be disposed through a center (not shown) ofimplant 160. In other embodiments, substance interface 168 can bedisposed anywhere on and/or through implant 160, e.g., offset fromcenter. Substance interface 168 can be substantially circular(cylindrical). In other embodiments, substance interface 168 can beother shapes and/or can be shaped based on a shape of the fastenermember, for example, rectangular (cuboid). In some embodiments,substance interface 168 can be an irregular shape, based at least inpart in the location of substance interface 168. While depicted in FIG.7 as including one substance interface, implant 160 can include morethan one substance interface 160. The location, size, shape, and/ornumber of substance interface(s) 168 can be determined based on thelocation, size, shape, and/or number of fastener interface(s) 166.

In one embodiment, a device for restoring the spacing between two facetsof a facet joint is provided. As shown in FIGS. 8A and 8B, the devicecomprises a implant 34 with a least two faces, a first face 36 adaptedto contact the articular surface of one facet of the facet joint and asecond face 38 adapted to contact the articular surface of the otherfacet. In one embodiment, the implant 34 has a generally circularprofile and is sized to fit generally within the joint capsule of thefacet joint 28. FIG. 8C illustrates the implant 34 of FIGS. 8A and 8Bpositioned in a facet joint. In other embodiments, the implant can haveany of a variety of profiles, including but not limited to square,rectangle, oval, star, polygon or combination thereof. An octagonalimplant is shown in FIGS. 9A and 9B. In one embodiment, a implant havingthe desired shape is selected from an array of prostheses afterradiographic visualization of the articular processes and/or byradio-contrast injection into the facet joint to visualize the jointcapsule. In one embodiment, the implant has a diameter of about 4 mm toabout 30 mm. In another embodiment, the implant has a diameter of about5 mm to about 25 mm. In still another embodiment, the implant has adiameter of about 10 mm to about 20 mm. In one embodiment, the implanthas a cross-sectional area of about 10 mm² to about 700 mm². In anotherembodiment, the implant has a cross-sectional area of about 25 mm² toabout 500 mm². In still another embodiment, the implant has across-sectional area of about 20 mm² to about 400 mm², or about 25 mm²to about 100 mm².

The implant has a thickness generally equal to about the anatomicspacing between two facets of a facet joint. The implant generally has athickness within the range of about 0.5 mm to about 3.0 mm. In certainembodiments, the implant has a thickness of about 1 mm to about 2 mm. Inone preferred embodiment, the implant has a thickness of about 0.5 mm toabout 1.5 mm. In one embodiment, the thickness of the implant isnonuniform within the same implant. For example, in FIGS. 10A and 10B,the thickness of the implant 42 is increased around the entire outeredge 44, along at least one and, as illustrated, both faces 46, 48. InFIGS. 11A and 11B, only a portion of the edge 44 on one face 46 of theimplant 42 has a thickness that is greater than the thickness of acentral region, and, optionally, also thicker than the typical anatomicspacing between two facets of a facet joint. An increased edge thicknessmay resist lateral displacement of the implant out of the facet joint.

In some embodiments, the implant is configured to provide an improvedfit with the articular process and/or joint capsule. For example, inFIGS. 12A and 12B, the implant 49 has a bend, angle or curve 50 togenerally match the natural shape of an articular facet. FIG. 13 depictsthe implant of FIGS. 12A and 12B positioned in a facet joint. Theimplant may be rigid with a preformed bend. Alternatively, the implantmay be sufficiently malleable that it will conform post implantation tothe unique configuration of the adjacent facet face. Certainembodiments, such as those depicted in FIG. 8C and FIG. 13, the implantis configured to be implanted between the articular processes and/orwithin the joint capsule of the facet joint, without securing of theimplant to any bony structures. Such embodiments can thus be usedwithout invasion or disruption of the vertebral bone and/or structure,thereby maintaining the integrity of the vertebral bone and/orstructure.

In one embodiment, at least a portion of one surface of the implant ishighly polished. A highly polished portion of the implant may reduce thesurface friction and/or wear in that portion of the implant as itcontacts bone, cartilage or another surface of the implant. A highlypolished surface on the implant may also decrease the risk of theimplant wedging between the articular surfaces of the facet joint, whichcan cause pain and locking of the facet joint.

In one embodiment, shown in FIGS. 14A and 14B, at least a portion of onesurface of the implant 50 has a roughened surface 52. A roughenedsurface may be advantageous when in contact with a bone or tissuesurface because it may prevent slippage of the implant 50 against thebone and aid in maintaining the implant 50 in the joint. In oneembodiment, shown in FIGS. 15A and 15B, at least a portion of onesurface of the implant 50 has a porous surface 54. A porous surface 54can be created in any a variety of ways known in the art, such as byapplying sintered beads or spraying plasma onto the implant surface. Aporous surface 54 can allow bone to grow into or attach to the surfaceof the implant 50, thus securing the implant 50 to the bone. In oneembodiment, an adhesive or sealant, such as a cyanoacrylate,polymethylmethacrylate, or other adhesive known in the art, is used tobond one face of the implant to an articular surface.

In one embodiment, one surface of the implant is roughened or porous anda second surface that is highly polished. The first surface contacts orengages one facet of the facet joint and aids in maintaining the implantbetween the articular surfaces. The second surface of the implant ishighly polished and contacts the other facet of the facet joint toprovide movement at that facet joint. FIGS. 16A and 16B represent oneembodiment of the implant comprising a curved or bent disc 56 with aroughened surface 52 on the greater face 58 of the disc and a highlypolished surface 60 on the lesser face 62. FIG. 17 depicts the implantof FIGS. 16A and 16B positioned in a facet joint. The implant generallymaintains a fixed position relative to the facet contacting theroughened surface while the movement of the facet joint is preservedbetween the other facet and the highly polished lesser face of theimplant.

FIGS. 18A and 18B show one embodiment, where the implant 64 comprisestwo separate discs 66, each disc comprising a first face 68 thatarticulates with the complementary first face 68 of the other disc, anda second face 70 adapted to secure the disc to the adjacent bone orcartilage of one facet of the facet joint 28. In one embodiment, thethickness of one disc will generally be about half of the anatomicspacing between two facets of the facet joint. In other embodiments, theimplant comprises three or more discs. In one embodiment the totalthickness of all the discs is generally about 25% to about 300% of theanatomic spacing between the two facets. In another embodiment, thetotal thickness of the discs is generally about 50% to about 150% of theanatomic spacing. In still another embodiment, the total thickness ofthe discs is about 75% to about 125% of the anatomic spacing. Each discof the two-part implant can otherwise also have features similar tothose of a single-disc implant, including but not limited to curved orbent configurations, highly polished or roughened surfaces, and otherfeature mentioned below. The two discs need not have the same size,thickness, configuration or features. FIG. 19 depicts one embodiment ofa two-part implant 64 positioned within a facet joint 28.

The implant can be manufactured from any of a variety of materials knownin the art, including but not limited to a polymer such aspolyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene,fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia,alumina, or silicon nitride; a metal such as titanium, titanium alloy,cobalt chromium or stainless steel; or any combination of the abovematerials.

In one embodiment, the implant is maintained between the two facets ofthe facet joint by taking advantage of the joint capsule and/or otherbody tissue surrounding the facet joint to limit the migration of theimplant out of the facet joint. In some embodiments, the shape of theimplant itself is capable of resisting displacement of the implant fromits position generally between the facet joint surfaces. In oneembodiment, a concave or biconcave configuration resists displacement ofthe implant by providing an increased thickness at the periphery of theimplant that requires a larger force and/or greater distraction of facetjoint surfaces in order to cause displacement. In other embodiments,surface treatments or texturing are used to maintain the implant againsta facet of the facet joint, as described previously. In someembodiments, a combination of disc configuration, surface texturing andexisting body tissue or structures are used to maintain the position ofthe implant.

Bone growth facilitators, electrical current, or other known techniquesmay be used to accelerate osteoincorporation of textured or microporousanchoring surfaces.

The implant may be configured with a fastener interface to engage(“secure”) a fastener member that facilitates retention of the implantwithin the joint capsule of the facet joint. Use of a fastener membermay be advantageous for preventing migration of the implant over timeuse or with the extreme ranges of vertebral movement that may distractthe articular surfaces sufficiently to allow the implant to slip out.

In one embodiment, shown in FIGS. 20 to 21B, the fastener membercomprises a wire or cable 72 with a portion 74 that engages the implant76 at a fastener interface 78, and at least one other portion 80 thatengages or anchors to the bone or soft tissue surrounding the facetjoint. The wire or cable may be solid, braided or multi-filamented. Thefastener member in this embodiment will be described primarily as acable or wire, but it is to be understood that any of a variety ofelongate structures capable of extending through a central aperture willalso work, including pins, screws, and single strand or multistrandpolymeric strings or weaves, polymeric meshes and fabric and otherstructures that will be apparent to those of skill in the art in view ofthe disclosure herein.

The cross-sectional shape of the fastener member can be any of a varietyof shapes, including but not limited to circles, ovals, squares,rectangles, other polygons or any other shape. The wire or cablegenerally has a diameter of about 0.5 mm to about 2 mm and a length ofabout 5 mm to about 60 mm. In other embodiments, wire or cable has adiameter of about 0.25 mm to about 1 mm, or about 0.75 mm to about 1.25mm. The diameter of the wire or cable may vary along the length of thewire or cable. In one embodiment, the wire or cable has a length ofabout 10 mm to about 40 mm. In another embodiment, the wire or cable hasa length of about 20 mm to about 30 mm.

In one embodiment, shown in FIGS. 21A and 21B, the fastener interface 78of the implant 76 is a conduit between the two faces 82, 84 of theimplant 76, forming an aperture 78. In one embodiment, the aperture 78has a diameter larger than the diameter of the wire or cable 72, toprovide the implant 76 with a range of motion as the facet joint moves.The aperture 78 inside diameter may be at least about 110%, often atleast about 150% and in certain embodiments at least about 200% or 300%or greater of the outside diameter or corresponding dimension of thefastener member in the vicinity of the engagement portion 78. Thecross-sectional shape of the aperture 78 can match or not match thecross sectional shape of the wire or cable used.

In another embodiment, the fastener interface 78 extends only partiallythrough the implant 72. The fastener interface 78 may be locatedgenerally in the center of the implant, or it may be locatedeccentrically, as depicted in FIGS. 22A and 22B. In one embodiment,shown in FIGS. 23A and 23B, the fastener interface 78 is located at theedge 86 of the implant 76 such that the interior surface of the hole 78is contiguous with the outer edge of the implant. This configuration ofthe fastener interface 78 does not require the cable 72 to be threadedthrough the fastener interface 78 and may facilitate engagement of thefastener member with the implant. FIGS. 24A and 24B depict an embodimentcomprising a two-part implant 88. Either a single cable or two separatecables may be used retain both discs within the facet joint. FIGS. 25Aand 25B depict another embodiment comprising a curved implant 90 with afastener interface 78 adapted to accept a cable.

In FIG. 26, the wire or cable 72 is secured to the articular processes20, 22 by tying one or more knots 92 in the cable 72 that can resistpulling of the wire or cable through the articular process. In anotherembodiment, one or both ends of the wire or cable are provided with ananchor to resist migration of the implants. As shown in FIGS. 27A and27B, one or both ends of the wire or cable 72 may be threaded such thata nut 94 can be tightened on the wire or cable 72 to secure the wire orcable to the articular processes 20, 22. FIG. 28 depicts the attachmentof a nut onto a threaded end of a cable. The threaded portion 96 of thewire or cable can be secured to the cable by pressing, crimping ortwisting the threaded 96 portion onto the cable 72. In one embodiment,the threaded portion 96 is made from titanium, titanium alloy, cobaltchromium, stainless steel, or any combination thereof.

In one embodiment, the wire or cable has two threaded ends 96 forengaging the bony or cartilaginous tissue, one portion for each facet ofthe facet joint.

In another embodiment, shown in FIG. 29, the wire or cable is secured tothe articular process with fastener rings 98. As depicted in FIGS. 30Aand 30B, the fastener rings 98 comprise a ring 100 with a central lumen102 and a locking element to facilitate locking the ring 100 to afastener member. The central lumen 102 is adapted to accept insertion ofa wire or cable through it. The illustrated locking element is in theform of a side lumen 104 which is threaded and configured to accept arotatable screw 106 with a proximal end 108, a threaded body 110 and adistal end 112. The threaded body 110 is complementary to the threads ofthe side lumen 104 so that when the screw 106 is rotated at its distalend 112, the proximal end 108 of the screw 106 moves further into thecentral lumen 102 and is capable of applying increasing force to a wireor cable inserted through the central lumen 102. In one embodiment, theforce on the wire or cable is capable of creating a friction fit or amechanical interfit to resist movement between the wire or cable and thefastener ring 98, thereby securing the wire or cable to the articularprocess 20 or 22. As shown in FIGS. 31 to 33, the distal end 112 of thescrew 106 can be configured to engage the wire or cable in any of avariety designs, including but no limited to a blunt tip 114, curved tip116 and piercing tip 118.

In another embodiment, depicted in FIGS. 34A and 34B, the wire or cableis securable to the articular process with a fastener ring 120 haveradially inward biased projections 122 defining a central lumen 124. Thecentral lumen has a cross-sectional shape smaller than that of the wireor cable but is capable of enlargement when the inward projections 122are bent away, as shown in FIGS. 35A and 35B. The inward projections 122apply increasing force to the wire or cable within the central lumen 124as the projections 122 are bent, thereby creating a friction fit.

In one embodiment, one end of the wire or cable fastener member ispreformed with a retainer for engaging the articular process. Theretainer may be a preformed ring, bulb, flared end, T-bar end, or any ofa variety of shapes having a greater cross sectional area than the otherportions of the wire or cable fastener member. This configuration of thewire or cable fastener member is adapted to engage an articular processby passing the free end of a wire or cable fastener member through anarticular process such that the end with the preformed retainer canengage the articular process.

In one embodiment, the wire or cable fastener member is secured to thearticular processes with sufficient laxity or length between the securedends or between the implant and one secured end so that the twoarticular processes are not fixed in position relative to each other andremain capable of performing movements such as flexion, extension,lateral flexion and/or rotation. In one embodiment, the fastener membercomprises a cable of braided polymer, including but not limited to abraided polymer such as PEEK or PEKK, or a braided metal, such asbraided cobalt chromium or titanium. The cable can be selected withdifferent degrees of flexibility to provide different degrees ofmovement at that facet joint. The cable has a first segment capable ofengaging the implant at its fastener interface to limit the movement.

In one embodiment, shown in FIG. 36A, the fastener member comprises ascrew or bolt 126 with a proximal end 128, body 130 and distal end 132.The distal end 132 of the screw or bolt is capable of forming amechanical interfit with a complementary fastener interface 134 on theimplant or spacer 136. The distal end 132 typically comprises threads,but other configurations may be used to form a mechanical interfit. Thecomplementary fastener interface 134 on the implant 136 could be athreaded through hole or, a close-ended hole. The proximal end 128 ofthe screw or bolt 126 has a hex or other type of interface known in theart, capable of engaging a rotating tool to manipulate the screw or bolt126. The body of the screw or bolt 126 has a length sufficient to atleast span the length of the hole or conduit created through thearticular process for securing the implant. In FIG. 36B, the fastenermember further comprises a pivotable washer 127 with a pivot surface 129that articulates with the proximal end 128 of the screw 126. In oneembodiment, the pivotable washer 127 is capable of a range of positionsrelative to the screw 126 and provides the screw 126 with a bettersurface area contact with the bone.

FIG. 37 is a cross-sectional view of a facet joint 28 with a spacer 136bolted to one articular process 20 of a facet joint 28. The spacer 136position is fixed relative to one facet 24 of the joint 28, but providesfor spacing and movement of the other facet 26 with respect to thespacer 136. In embodiments comprising a two-part implant, shown in FIGS.38 and 39, each disc may have its own screw or bolt fastener member.FIG. 38 depicts a flat two-part implant 138 and FIG. 39 depicts a curvedtwo-part implant 140.

In some embodiments, shown in FIGS. 40A through 41B, the fastener memberis integral with or attached to the implant and comprises a projection142 from the implant 144 that is adapted to engage the adjacentarticular process or surrounding tissue. In one embodiment, theprojection comprises at least one spike 142 or hook projecting from oneface of the implant 144. In one embodiment, the spike 142 or hook can beribbed, barbed or threaded to resist separation after insertion intobone or tissue. FIG. 42 depicts the implant 144 of FIG. 40A engaged to afacet 24 of the facet joint 28. In one embodiment comprising a two-partimplant 146, shown in FIG. 43, each disc 148 may have its ownprojection-fastener member 142. In some embodiments, as depicted in FIG.44, more than one projection 150 is provided on the implant 152. FIG. 45illustrates the implant of FIG. 44 placed in a facet joint 28. Theprojections 150 may be angled with respect to the implant 152 to resistdislodgement by the movement at the joint.

FIGS. 46A to 47B illustrate embodiments where the fastener membercomprises a projection 154 extending laterally such as from the side ofthe implant 156, and adapted to engage the soft tissue surrounding thefacet joint, rather than a bony or cartilaginous articular process. Inone example, the implant of FIG. 46 could be inserted into a facet jointthrough an incision made in the joint capsule, but the integrity of thejoint capsule opposite the incision site is maintained and used as ananchoring site for the implant. The orientation of the projection can befixed as in FIG. 44, or flexible. FIG. 47 depicts a flexible tether suchas a wire 158 with its proximal end 160 embedded in or otherwiseattached to the implant and one or more barbs which may be attached toits distal end 162. A flexible projection may provide greater selectionof soft tissue anchoring sites for the implant.

In one embodiment, the joint capsule is closed after placement of theimplant. Closure may be performed using adhesives, suturing, stapling orany of a variety of closure mechanisms known in the art.

FIGS. 48A-48C depict an implant 260 according to an embodiment.

Specifically, FIG. 48A is a front perspective view of implant 260, FIG.48B is a side view of implant 260, and FIG. 48C is a cross-sectionalside view of implant 260. Implant 260 can be similar to, and havesimilar elements and uses as implant 160 described above. By way ofexample, a fastener interface 266 of implant 260 can be similar tofastener interface 166 of implant 160. Implant 260 includes a concavefirst face 262, a convex second face 264, a centrally disposed circularfastener interface 266, and four irregular shaped substance interfaces268.

FIGS. 49-51 show posterior perspective views of a portion of thevertebral column during a method for fusing adjacent vertebrae using animplant 260 according to an embodiment. As shown in FIG. 49, implant 260and a fastener member 280 can be used to fuse a vertebra V1 and vertebraV2 via the inferior articular process IAP1A of vertebra V1 and thesuperior articular process SAP2A of vertebra V2. Any fastener member caninclude any biocompatible material, e.g., stainless steel, titanium,PEEK, nylon, etc. Also as shown in FIG. 49, an implant 360 and afastener member 380 are used to fuse a vertebra V1 and vertebra V2 viathe inferior articular process IAP1B of vertebra V1 and the superiorarticular process SAP2B of vertebra V2. In some embodiments, vertebra V1and/or vertebra V2 are fused using only one of implant 260 or implant360. In some such embodiments, one of implant 260 and fastener member280 or implant 360 and fastener member 380 can be used to stabilizevertebra V1 and/or vertebra V2 via one of via the inferior articularprocess IAP1A of vertebra V1 and the superior articular process SAP2A ofvertebra V2, or, via the inferior articular process IAP1B of vertebra V1and the superior articular process SAP2B of vertebra V2. In other suchembodiments, one of fastener member 280 or fastener member 380 can beused to stabilize vertebra V1 and/or vertebra V2 via both of theinferior articular process IAP1A of vertebra V1 and the superiorarticular process SAP2A of vertebra V2 (for example, in combination withimplant 260), and, the inferior articular process IAP1B of vertebra V1and the superior articular process SAP2B of vertebra V2 (for example, incombination with implant 360).

FIG. 52 depicts a flow chart illustrating a method 6000 of using implant260 with fastener member 280 and/or implant 360 with fastener member380. Prior to use of implant 260 and/or implant 360, a patient can beprepared for surgery, at 6002. Some examples of preparations for surgeryare described in U.S. patent application Ser. No. 12/859,009; filed Aug.18, 2010, and titled “Vertebral Facet Joint Drill and Method of Use”(referred to as “the '009 application”), and is incorporated herein byreference in its entirety. In addition to those procedures described inthe '009 application, in some embodiments, the surgical procedure caninclude direct visualization of the vertebra(e) to be stabilized. Saidanother way, the medical practitioner can perform the operation withoutthe use of fluoroscopy. This direct visualization can be possible due tothe small incision necessary for implantation of the implant, forexample, less than about 25 mm, and due to the ease of implanting anddeploying the implant. In some embodiments, the surgical procedure usedcan include forming an opening in body tissue substantially equidistantbetween a first articular process of the first vertebra and a secondarticular process of the first vertebra. A cannula (not shown) can beinserted through the opening and a proximal end of the cannula can bepositioned near the superior articular process SAP2A of vertebra V2. Insome embodiments, the surgical procedure can include preparing the areanear and/or around the vertebra V2 by, for example, removing all or aportion of ligaments, cartilage, and/or other tissue. For example, thearea near and/or around a facet joint can be prepared by removing all ora portion of the facet joint capsule.

A drill or other device can be used to form a lumen in superiorarticular process SAP2A of vertebra V2 and inferior articular processIAP1A of vertebra V1, at 6004. Specifically, the drill can be used toform the lumen in a facet of superior articular process SAP2A ofvertebra V2 and to form the lumen in a facet of inferior articularprocess IAP1A of vertebra V1. Methods and devices for forming lumens invertebra are described in the '009 application. A portion of the surfaceof the facet of SAP2A and IAP1A can be prepared for fusion, at 6006.Specifically, a portion of the surface of the facet can be ground,scored, roughened, sanded, etc, such that the surface of the facet canbetter adhere to any substances to aid in fusion and/or otherwise fusemore readily to the implant. The fastener member 280 can be positionedwithin the cannula and can be advanced through the cannula until aproximal end portion 282 of fastener member 280 is positioned near thelumen of superior articular process SAP2A of vertebra V2. In someembodiments, the proximal end of the cannula can have a bend to directthe proximal end portion 282 of fastener member 280 into the lumen ofsuperior articular process SAP2A of vertebra V2. The proximal endportion 282 of fastener member 280 is inserted into the lumen ofsuperior articular process SAP2A of vertebra V2, at 6008. A substancecan be disposed in a substance interface 268 of implant 260, at 6010. Insome embodiments, implant 260 can have a substance disposed in substanceinterface 268 prior to a surgical procedure, for example, duringmanufacturing of implant 260, post-manufacturing, and/or as part of akit. Implant 260 is inserted between the superior articular processSAP2A of vertebra V2 and inferior articular process IAP1A of vertebraV1, at 6012.

The proximal end portion 282 of fastener member 280 is inserted into thelumen of inferior articular process IAP1A of vertebra V1, at 6014. Thefastener member can be secured, at 6016. Securing the fastener member280 can be based on the type of fastener member used. By way of example,securing a fastener member similar to a flexible fastener band asdepicted in FIGS. 49-51, can include inserting the proximal end portion282 into a fastening mechanism of a distal end portion 284 of thefastener member 280, and advancing the proximal end portion 282 throughthe fastening mechanism to secure the fastening mechanism. In otherembodiments, fastener member can be secured by tying a first portion thefastener member to a second portion of the fastener member, by screwingthe fastener member into a threaded fastener interface, threading afastener onto a threaded end of a fastener member disposed through afastener interface, combinations of above, etc. In some embodiments,implant 260 can be disposed prior to inserting the proximal end portionof the fastener member 280 into the lumen of superior articular processSAP2A of vertebra V2. The cannula can be removed and/or reinserted atvarious points during the method 6000, including, for example, after theproximal end portion 282 of fastener member 280 is inserted into thelumen formed within the superior articular process SAP2A of vertebra V2,after vertebra V1 and/or Vertebra V2 has been stabilized, or at otherpoints during method 6000.

After the fastener member is secured, superior articular process SAP2Aof vertebra V2 can fuse to inferior articular process IAP1A of vertebraV1. Fusing can include one or more of bone material from superiorarticular process SAP2A of vertebra V2, bone material from inferiorarticular process IAP1A of vertebra V1, and the substance that fusesarticular process SAP2A of vertebra V2 to inferior articular processIAP1A of vertebra V1 through substance interface 268. In someembodiments, after superior articular process SAP2A of vertebra V2 isfused to inferior articular process IAP1A of vertebra V1, the fastenermember 280 is not removed. In some other embodiments, after superiorarticular process SAP2A of vertebra V2 is fused to inferior articularprocess IAP1A of vertebra V1, all or a portion of the fastener member280 can be removed. In other embodiments, fastener member 280 can beremoved after fusion of superior articular process SAP2A of vertebra V2to inferior articular process IAP1A of vertebra V1 has started, but hasnot finished.

In addition to the fastener members shown above, such as, for example,fastener member 260, FIGS. 53-65 show fastener members according toother embodiments.

FIG. 53 depicts views of a fastener member 480. Fastener member 480 canbe a flexible fastening band (“band”) 480, FIG. 54 depicts a view of aportion of band 480 can be similar to band 280 described above and caninclude similar components. By way of example, band 480 includes aproximal end portion 482, a first portion 484, a second portion 486, anda distal end portion 488 including a fastening mechanism 490. Incontrast to band 280, band 480 includes a cylindrical second portion 486and each includes a third portion 489. As depicted in FIGS. 53-54, thirdportion 489 is substantially the same shape as first portion 482. Asshown in FIGS. 53 and 54, band 480 includes a gear rack 487 and gears494. Each of gears 494 can be wedge shaped to allow each of gears 494 todisplace the ratchet of fastening mechanism 490 in only one direction.In some embodiments, gears 494 can be other shapes, such as blocks, etc.

FIG. 55 is a side view and FIG. 56 is a top view of a fastener member840. Fastener member 840 can be a flexible fastening band (“band”) 580according to another embodiment. Band 840 can be similar to band 280 andband 480 described above and can include similar components. By way ofexample, band 840 includes a proximal end portion 842, a first portion844 including a gear rack 847, a second portion 846, and a distal endportion 848 including a fastening mechanism 850 and a ratchet 862. Incontrast to gear rack 487, a cross sectional area of each gear 864 ofgear rack 847 is rectangular in shape instead of wedge shaped.Furthermore, in contrast to first portion 282, first portion 844 iscylindrical in shape instead of cuboidal in shape. In this manner, thelumen 866 of the fastening mechanism 850 is cylindrical in shape. A bandaccording to this embodiment may be particularly useful in deploymentswhere a single band in used to stabilize adjacent vertebrae. In thismanner, the second portion can be disposed within the lumen of the firstarticular process of the first vertebra and a portion of the firstportion can be disposed within the lumen of the second articular processof the first vertebra. In these embodiments the portion of the bandwithin the first articular process of the first vertebra and the portionof the band within in the second articular process of the first vertebracan both have substantially the same shape as the lumen in the firstarticular process of the first vertebra and the lumen in the secondarticular process of the first vertebra. In this manner, and asdescribed above regarding band 480, the amount of open space within thelumens can be minimized, the amount of surface area of the first portionand/or second portion of the band in contact with the lumens canincrease, and subsequently the movement of the first vertebra and/or thesecond vertebra can be reduced or minimized. Furthermore, when movementof the first vertebra and/or the second vertebra does occur, forcesacting against the band can be more equally distributed throughout thefirst portion and/or the second portion, due at least to the increasedsurface area of the band in contact with the lumens.

FIG. 57 is a side view a fastener member 940. Fastener member 940 can bea flexible fastening band (“band”) 940 according to an embodiment. Band940 can be similar to band 280, band 480, and band 840 described aboveand can include similar components. By way of example, band 840 includesa proximal end portion 942, a first portion 944 including a gear rack947, a second portion 946, and a distal end portion 948 including afastening mechanism 950. Similar to gear rack 847, a cross sectionalarea of each gear 964 of gear rack 947 is rectangular in shape. Incontrast to gear rack 847, each of gears 964 extend the entirecircumference of first portion 944 instead of only a portion of thecircumference of first portion 944. Furthermore, in contrast to firstportion 282, but similar to first portion 844, first portion 944 iscylindrical in shape instead of cuboidal in shape. In this manner, thelumen 966 of the fastening mechanism 950 is cylindrical in shape. A bandaccording to this embodiment may be particularly useful in deploymentswhere the movement and repositioning of the band after implantation maybe difficult. In this manner, because each of the gears can be theentire circumference of the first portion and/or the second portion, thefirst portion and/or the second portion can enter the fasteningmechanism in any radial orientation and still engage the ratchet.

FIGS. 58-62 are views of a fastener member 780. Fastener member 780 canbe a flexible fastening band (“band”) 780 according to anotherembodiment. FIG. 58 is a perspective view and FIG. 59 is across-sectional side view of band 780. FIG. 60 is a cross-sectional viewof band 780 taken along line XXIII. FIG. 61 is a cross-sectional topview of band 780 in a first configuration and FIG. 62 is across-sectional top view of band 780 in a second configuration. Band 780can be similar to band 280 and band 480 described above and can includesimilar components. By way of example, band 780 includes a proximal endportion (not shown), a first portion 784 including a gear rack 787 (seeFIG. 59), a second portion 786, and a distal end portion 788 including afastening mechanism 790 and a ratchet 792. In contrast to band 280 andband 480, band 780 includes a reinforcement piece 772.

Reinforcement piece 772 can include any of the materials described abovefor a fastener member. In some embodiments, reinforcement piece 772 caninclude a material stronger than second portion 786 and/or first portion784, for example, first portion 784 and second portion 786 can includePEEK and reinforcement piece 772 can include titanium. As shown in FIG.59, reinforcement piece 772 can be disposed within band 780approximately along the entire length of second portion 786, and aportion of reinforcement piece 772 can be disposed within the distal endportion 788. In some embodiments, reinforcement piece can include alength along at least a portion of the length of second portion 786and/or first portion 784 but not the distal end portion. In someembodiments, reinforcement piece 772 can be disposed only within secondportion 786. Reinforcement piece 772 can have a length in firstdimension (length), a length in a second dimension (width), and a lengthin a third dimension (height). As described herein, a reinforcementpiece be different shapes that can include more or fewer dimensions.

The reinforcement piece can be molded within the band. Said another way,in embodiments where the first portion, the second portion, and or thedistal end portion are moldable materials, the reinforcement piece canbe placed in the mold and the moldable materials can be injected orotherwise put in the mold around the reinforcement piece. In otherembodiments, each portion of the band (for example, the proximal endportion, the first portion, the second portion, the third portion,and/or the distal end portion) around the reinforcement piece can have atop half and a bottom half, and each of the top half and the bottom halfcan be placed around the reinforcement piece, and sealed. As shown inFIG. 61, reinforcement piece 772 includes support members 774. WhileFIG. 61 shows reinforcement piece 772 including four support members774, in some embodiments, more or fewer support members 774 can be used.Support members 774 can maintain the position of reinforcement piece 772during the molding and/or assembly process of band 780. As shown in FIG.62, support members 774 are removed before band 780 is used.

As shown in FIG. 60, reinforcement piece 772 can has a substantiallyuniform cuboidal shape. In other embodiments, reinforcement piece 772can have other shapes. The shape of the reinforcement piece can beselected depending on the desired bending and/or torsion characteristicsof the material chosen. By way of example, a substantially planarcuboidal shape can provide a greater increase in bending strength whileproviding a lesser increase in torsion strength, a cylindrical shape canprovide an increase in bending strength while providing very littleincrease in torsion strength, a substantially square and/or tubularcuboidal shape can provide similar bending and torsion increases. Anyshape can be selected to achieve the desired bending and torsionstrength. Combinations of materials and shapes can also be considered.For example, a material having higher torsion strength may be combinedwith a shape having a lower torsion strength to combine for the desiredtorsion strength. As shown in FIGS. 61 and 62, reinforcement piece 772includes holes 776 distributed along the length of the first dimension.While FIGS. 61 and 62 shows band 780 including many holes 776, in someembodiments, more or fewer holes 776 can be used. FIGS. 61 and 62 depictholes 776 distributed substantially equally along the length of thefirst dimension, in some embodiments, the holes can be distributeddifferently or along different dimensions depending on the shape and/ormaterial chosen, and/or whether the reinforcement piece is solid orhollow. Holes 776 can be configured to reduce the weight ofreinforcement piece 772 while still provided band 780 additionalstrength. Holes 776 can be round, oval, square, or any other shape.

FIG. 63 is an exploded view, FIG. 64 is a perspective view, and FIG. 65is a cross-sectional view of a fastener member 880. Fastener member 880can be a flexible fastening band (“band”) 880 according to anotherembodiment. Band 880 can be similar to band 280 and band 480 describedabove and can include similar components. By way of example, band 880includes a proximal end portion 882, a first portion 884, a secondportion 886 including a gear rack 887, a distal end portion 888, afastening mechanism 890 and a ratchet 892. In contrast to band 280 andband 480, the fastening mechanism 890 of band 880 is separately formedfrom distal portion 888 of band 880. While second portion 886 of band880 is shown in FIGS. 63-65 as having a substantially cuboidal shape, insome embodiments, second portion 886 can be substantially cylindrical inshape or any other appropriate shape discussed herein. As shown in FIGS.64 and 65, band 880 includes a gear rack 887 and gears 894. Each ofgears 894 can be wedge shaped to allow each of gears 894 to displace aratchet 892 of fastening mechanism 890 in only one direction. In someembodiments, gears 894 can be other shapes, such as blocks, or any otherappropriate shape discussed herein. As shown in FIGS. 63-65, distal endportion 888 can be substantially circular in shape and can have adiameter greater than a width of second portion 886. In otherembodiments, distal portion 888 can have other shapes, for example,oval, rectangular, square, etc.

In addition to the implants shown above, such as, for example, implant160, FIGS. 66-81 show implants according to other embodiments.

FIGS. 66-69 depict an implant 1060 according to an embodiment.Specifically, FIG. 66 is a front perspective view of implant 1060, FIG.67 is a rear perspective view of implant 1060, FIG. 68 is a side view ofimplant 1060, and FIG. 69 is a cross-sectional side view of implant1060. Implant 1060 can be similar to, and have similar elements and usesas implant 160 and implant 260 described above. By way of example, afastener interface 1066 of implant 1060 can be similar to fastenerinterface 166 of implant 160, and similar to fastener interface 266 ofimplant 260 Implant 1060 includes a concave first face 1062, a convexsecond face 1064, a centrally-disposed substantially-circular fastenerinterface 1066, and six substantially-circular shaped substanceinterfaces 1068.

FIGS. 70-73 depict an implant 1160 according to an embodiment.Specifically, FIG. 70 is a front perspective view of implant 1160, FIG.71 is a rear perspective view of implant 1160, FIG. 72 is a side view ofimplant 1160, and FIG. 73 is a cross-sectional side view of implant1160. Implant 1160 can be similar to, and have similar elements and usesas implant 160 and implant 260 described above. By way of example, afastener interface 1166 of implant 1160 can be similar to fastenerinterface 166 of implant 160, and similar to fastener interface 266 ofimplant 260. Implant 1160 includes a concave first face 1162, a convexsecond face 1164, a centrally-disposed substantially-circular fastenerinterface 1166, and five rounded rectangular shaped substance interfaces1168.

FIGS. 74-77 depict an implant 1260 according to an embodiment.Specifically, FIG. 74 is a front perspective view of implant 1260, FIG.75 is a rear perspective view of implant 1260, FIG. 76 is a side view ofimplant 1260, and FIG. 77 is a cross-sectional side view of implant1260. Implant 1260 can be similar to, and have similar elements and usesas implant 160 and implant 260 described above. By way of example, afastener interface 1266 of implant 1260 can be similar to fastenerinterface 166 of implant 160, and similar to fastener interface 266 ofimplant 260. Implant 1260 includes a concave first face 1262, a convexsecond face 1264, a centrally-disposed substantially-circular fastenerinterface 1266, and several substantially-circular shaped andvariably-sized substance interfaces 1268.

FIGS. 78-81 depict an implant 1360 according to an embodiment.Specifically, FIG. 78 is a front perspective view of implant 1360, FIG.79 is a rear perspective view of implant 1360, FIG. 80 is a side view ofimplant 1360, and FIG. 81 is a cross-sectional side view of implant1360. Implant 1360 can be similar to, and have similar elements and usesas implant 160 and implant 260 described above. By way of example, afastener interface 1366 of implant 1360 can be similar to fastenerinterface 166 of implant 160, and similar to fastener interface 266 ofimplant 260. Implant 1360 includes a concave first face 1362, a convexsecond face 1364, a centrally-disposed substantially-circular fastenerinterface 1166, four irregular shaped substance interfaces 1368, andfour projections 1369. Each of the four projections 1369 can engage, orother wise dig, latch, lock, or hook into or onto, a bone portion toprevent or reduce movement of the implant 1360, such as, for example,rotation of implant 1360, longitudinal movement of implant 1360, and/orlateral movement of implant 1360. In this manner, the projections 1369can secure implant 1360 to a bone portion during a fusion procedure. Insome embodiments, projections 1369 can substantially maintain a positionof implant 1369 after a fastener member is removed.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, notlimitation, and various changes in form and details may be made. Forexample, while the descriptions given are with reference to stabilizingvertebra, another bone(s), such as, for example, a sternum and/or arib(s) could be stabilized using the fastener members and implantsdescribed herein. In another example, a fastener member can be used tostabilize and/or fixate an intramedullary (IM) rod or nail. For example,the fastener member can be used at different longitudinal locationsalong an IM rod or nail, and used to couple adjacent bone portions tothe IM rod or nail. In such situations, a given fastener member can fixa first bone portion, the IM rod or nail, and a second bone portion, allof which are positioned between the distal portion and the proximalportion of the fastener member. In yet another example, a fastenermember can be used to stabilize and/or fixate a bone fragment. Whilevarious embodiments have been described above with regard to naturalbone spaces, (e.g., the space between an inferior articulate process anda superior articulate process), in other embodiments, the bone spacingcan be man-made (e.g., sternum split during a heart procedure), and/ordue to an injury (e.g., broken bone).

Where methods described above indicate certain events occurring incertain order, the ordering of certain events can be modified.Additionally, certain of the events can be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. Any portion of the apparatus and/or methods describedherein may be combined in any combination, except mutually exclusivecombinations. The embodiments described herein can include variouscombinations and/or sub-combinations of the functions, components and/orfeatures of the different embodiments described. For example, FIGS. 54and 56 depict band 580 including a single ratchet 592, and FIG. 57depicts band 680 including a single ratchet 692, however, in someembodiments, any of the fastener members can include any number ofratchets. Similarly, any of fastener members can include a reinforcementpiece and/or a implant. Furthermore, while one embodiment of an implantmay be shown in use with one embodiment of a fastener member, in otherembodiments, implants and fastener member can be used with otherimplants and fastener members. For example, while FIG. 28 depicts animplant being secured with a threaded wire, in some embodiments, aflexible fastening band can be used.

Facet Reinforcement Device

Although the flexible fastening band may be used alone or with anembodiment of facet implant as described above, in some applications itmay be desirable to reinforce the fixation of the band as it exits thebone of the articular process. This may prevent cut out by relievingpressure on the surface of the articular process and hold in the bonefrom the fastener band and/or fastening mechanism. The facetreinforcement may also anchor the flexible facet band to the vertebrausing a fastener. This may prevent migration of the band and restrictmotion at the facet joint to improve fusion.

FIG. 82 depicts one arrangement of facet reinforcement device 1400. Thefacet reinforcement device 1400 of the illustrated arrangement caninclude a proximal surface 1402, a distal surface 1406, an ablumenalsurface 1404 extending from the proximal surface 1402 to the distalsurface 1406. In certain arrangements, the proximal surface 1402 and/ordistal surface 1406 can be curved and/or malleable to conform to theshape of the facet. The facet reinforcement device 1400 can include aluminal surface 1410 surrounding a central lumen 1420. The luminalsurface 1410 can extend from the proximal surface 1402 to the distalsurface 1406. The central lumen 1420 can be centrally disposed withinthe device 1400. As described below, the luminal surface 1410 caninclude a fastener interface (not illustrated) in certain embodiments.

As will be explained below, the facet reinforcement devices describedherein can be used in combination with the implants depicted in FIGS.8A-81A and/or other implants described herein. The facet reinforcementdevice 1400 can also be used in combination with the fastener membersdepicted in FIGS. 20-65, and/or other fastener members described herein.Accordingly, the fastener member 1480 depicted in FIG. 84 can refer toany fastener member described herein; and the fastener member 1580depicted in FIG. 87 can refer to any fastener member described herein;and the fastener members 1680, 1680A depicted in FIG. 89 can refer toany fastener member described herein.

As shown in FIG. 82, at least a portion of one surface of the facetreinforcement device 1400 can include a roughened surface. A roughenedsurface may be advantageous when in contact with a bone or tissuesurface because it may prevent slippage or migration of the facetreinforcement device 1400 against the bone. A roughened surface may aidin maintaining the facet reinforcement device 1400 and the fastenermember 1480 (see FIG. 83) engaged with tissue or bone.

The roughened surface can include at least one projection 1416. As shownin FIG. 82, the facet reinforcement device 1400 can comprise a pluralityof projections 1416. The projections 1416 can extend from the distalsurface 1406 and can include a sharp edge or tip. The projections 1416can also extend between the ablumenal surface 1404 and the luminalsurface 1410 or in certain embodiments only extend along a portion ofsaid area. In some embodiments, the projections 1416 comprise at leastone spike, barb, wedge, or hook projecting from at least a portion ofone surface of the facet reinforcement device 1400. In some embodiments,the projections 1416 can be ribbed, barbed, or threaded to resistseparation after insertion into bone or tissue. The projections 1416 mayhave different shapes from one another or they may have a uniform shape.A portion of the surface of the projections 1416 can be porous. A poroussurface can be created in any a variety of ways known in the art, suchas by applying sintered beads or spraying plasma onto the surface of theprojection 1416. A porous surface can allow bone to grow into or attachto the surface of the projection 1416, thus securing the projection 1416and the facet reinforcement device 1400 to the bone. In certainembodiments, other surfaces of the facet reinforcement device 1400 canbe porous. In one embodiment, an adhesive or sealant, such as acyanoacrylate, polymethylmethacrylate, or other adhesive known in theart, is used to bond at least one surface of the facet reinforcementdevice 1400 to a bone or tissue surface. In some embodiments, anadhesive or sealant is used to bond the distal surface 1406 of the facetreinforcement device 1400 to the surface of the facet.

The facet reinforcement device 1400 may include one row of projections1416 or may include multiple rows of projections 1416. The facetreinforcement device 1400 may include projections 1416 arranged in arandom order or orientation.

The ablumenal surface 1404 of the facet reinforcement device 1400 caninclude a substantially circular cross-section (cylindrical), as shownin FIG. 82. The ablumenal surface 1404 can have other cross-sectionalshapes including, but not limited to, circular (cylindrical), hexagonal,rectangular (cuboid), square, elliptical, and/or have a combination ofcurved, flat surfaces and/or partial shapes. In certain embodiments, theablumenal surface 1404 may conform to the shape of an insertion tool.

In the illustrated embodiment of FIG. 82, the central lumen 1420 and theluminal surface 1410 can be circular (cylindrical). The central lumen1420 and the luminal surface 1410 can have other cross-sectional shapesincluding, but not limited to, hexagonal, rectangular (cuboid), square,elliptical, and/or have a combination of curved, flat surfaces and/orpartial shapes. The central lumen 1420 and the luminal surface 1410 mayconform to the shape of an insertion tool. In certain embodiments, thecentral lumen 1420 and the luminal surface 1410 can be shaped based on ashape of the fastener member (not shown) (e.g., the central lumen andluminal surface can have a similar cross-sectional shape as the fastenermember extending through the central lumen). In certain embodiments, thecentral lumen 1420 and the luminal surface 1410 can include asubstantially smooth inner surface to allow the fastener member 1480 toeasily pass through. In other embodiments, the central lumen 1420 andthe luminal surface 1410 can include a threaded inner surface to allowthe fastener member 1480 to thread into central lumen 1420.

The central lumen 1420 and the luminal surface 1410 may be configured tomatch the shape of a lumen formed in the articular process, during amethod of use. The central lumen 1420 and the luminal surface 1410 maybe smaller than a lumen formed in the articular process, during a methodof use. In this configuration, the facet reinforcement device 1400 mayreduce stress at the outer aspect of the lumen in the bone. The centrallumen 1420 and the luminal surface 1410 may be larger than a lumenformed in the articular process, during a method of use. In thisconfiguration, the facet reinforcement device 1400 may be in contactwith a larger surface area of the facet, thereby distributing the forcesof the fastener member.

The proximal surface 1402 may have a feature to mechanically interfitwith an insertion tool, including grooves and/or protrusions configuredto mate with a corresponding groove and/or protrusion of the insertiontool. The proximal surface 1402 may have a feature (e.g., a groove orrecess) to mechanically interfit with a portion of the fastener member1480 (shown in FIG. 84). The feature to mechanically interfit with aportion of the fastener member may increase stability of the system andresistance to migration of components of the system.

The diameter of the facet reinforcement device 1400 may be in the rangeof 2 mm-20 mm or in the range of 4 mm-15 mm. The diameter of the centrallumen 1420 may be in the range of 0.5 mm-10 mm or range of 1-7 mm.

FIGS. 83-84 show posterior perspective views of a portion of thevertebral column during a method for fusing adjacent vertebrae using theembodiment of the facet reinforcement device 1400 shown in FIG. 82. Themethod can include using an implant deployed to restore the spacebetween facets of a superior articular process of a first vertebra andan inferior articular process of an adjacent vertebra.

In one method of use, a drill or other device can be used to form alumen in superior articular process SAP2A of vertebra V2 and inferiorarticular process IAP1A of vertebra V1. A portion of the surface of thefacet of SAP2A and a portion of the surface of the facet of IAP1A can beprepared for fusion. For example, a portion of the surface of the facetcan be ground, scored, roughened, sanded, etc., such that the surface ofthe facet can better adhere to any substances to aid in fusion and/orotherwise fuse more readily to an implant positioned within the facetjoint.

FIG. 83 illustrates the facet reinforcement device 1400 placed on theouter, posterior facing surface of the left inferior articular processIAP1A of the superior vertebra V1. In other embodiments and/or inaddition, the facet reinforcement device can be placed on the surface ofthe facet of SAP2A. A lumen is formed in the articular process. Thefacet reinforcement device 1400 can be placed after a lumen is formed inthe articular process. In another arrangement, the facet reinforcementdevice 1400 can be placed prior to forming a lumen in the articularprocess. In this method, the facet reinforcement device 1400 may serveas a guide for drilling the lumen. The facet reinforcement device 1400can be placed after or prior preparation for fusion. An insertion toolmay remain on the facet reinforcement device 1400 during the steps offorming the lumen and/or during the step of preparing for fusion.

As shown in FIG. 84, a facet reinforcement device 1400 and a fastenermember 1480 can be used to fuse a vertebra V1 and vertebra V2 via theinferior articular process IAP1A of vertebra V1 and the superiorarticular process SAP2A of vertebra V2. In some embodiments, at leastone implant (not shown in FIG. 84) is used with the fastener member 1480to fuse a vertebra V1 and vertebra V2. FIG. 84 depicts fusing theinferior articular process IAP1A of vertebra V1 and the superiorarticular process SAP2A of vertebra V2. However, the inferior articularprocess IAP1B of vertebra V1 can be fused to the superior articularprocess SAP2B of vertebra V2.

In one method of use, the fastener member 1480 can be positioned withina cannula and can be advanced through the cannula. The proximal endportion of fastener member 1480 can then be inserted into the centrallumen 1420 of the facet reinforcement device 1400. The proximal endportion of the fastener member 1480 can be adjacent and/or abut theluminal surface 1410. The proximal end portion of fastener member 1480can then be inserted into the lumen of inferior articular process IAP1Aof vertebra V1. The proximal end portion of fastener member 1480 can beadvanced until a proximal end portion of fastener member is positionednear the lumen of superior articular process SAP2A of vertebra V2. Insome embodiments, the proximal end of the cannula can have a bend todirect the proximal end portion of fastener member 1480 into the lumenof superior articular process SAP2A of vertebra V2. The proximal endportion of fastener member 1480 can be inserted into the lumen ofsuperior articular process SAP2A of vertebra V2. An implant can beinserted between the superior articular process SAP2A of vertebra V2 andinferior articular process IAP1A of vertebra V1. In some embodiments,the implant can be disposed prior to inserting the proximal end portionof the fastener member 1480 into the lumen of superior articular processSAP2A of vertebra V2. The cannula can be removed and/or reinserted atvarious points during the method, including, for example, after theproximal end portion of fastener member 1480 is inserted into the lumenformed within the superior articular process SAP2A of vertebra V2, aftervertebra V1 and/or vertebra V2 have been stabilized, or at any otherpoint during the method.

The fastener member 1480 can be secured. Securing the fastener member1480 can be based on the type of fastener member used. By way ofexample, securing a fastener member 1480 having the characteristics ofthe fastener member depicted in FIGS. 49-51, can include the followingsteps: inserting the proximal end portion of the fastener member 1480into a fastening mechanism 1484; the fastener mechanism located at adistal end portion of the fastener member 1480; securing an end of thefastener member 1480 to the opposite end of the fastener member 1480;securing the proximal end portion of the fastener member 1480 to thedistal end portion of the fastener member 1480; and/or advancing theproximal end portion of the fastener member 1480 through the fasteningmechanism 1484. In other embodiments, fastener member 1480 can besecured by tying a first portion the fastener member to a second portionof the fastener member, by forming a knot in a first end and second end;by screwing the fastener member into a threaded central lumen, bythreading a fastener onto a threaded end of a fastener member disposedthrough a threaded central lumen, by including enlarged portion at theend of the fastener member, and/or combinations of above. The fastenermember 1480 can be secured in order to retain the facet reinforcementdevice 1400. The facet reinforcement device 1400 is retained within aloop or other defined segment of the fastener member 1480. Thereinforcement device 1400 can remain freely movable along a portion ofthe defined segment after the fastener member 1480 is secured. In someembodiments, the reinforcement device 1400 is immobile or otherwisesecured along a portion of the defined segment after the fastener member1480 is secured.

FIG. 84 illustrates the assembled system, including the facetreinforcement device 1400 and the fastener member 1480. The assembledsystem is implanted on the left facet joint 1490 between the superiorvertebra V1 and the inferior vertebra V2. The left facet joint 1490 maybe compressed by the assembled system, thereby bringing the two facetsurfaces in close apposition. This compression is in contrast with theunsecured right facet joint 1492.

A second facet reinforcement device 1400, a second fastener member 1480with or without a second implant may be implanted in the right facetjoint 1492, according to the method described above with respect to theleft facet joint 1490. The implantation of a second facet reinforcementdevice 1400 and a second fastener may improve stabilization. A secondfacet reinforcement device 1400 and a second fastener member 1480 withor without a second implant may be implanted on other levels of thespine. A plurality of reinforcement devices 1400 and a plurality offastener members 1480 with or without a plurality of implants may beimplanted on other levels of the spine, and at various locations on thespine. In some embodiments, the same and/or similar method of fixation,the same fastener members 1480, the same implants and/or the same facetreinforcement devices 1400 may be used at different locations. In otherembodiments, a different method of fixation, different fastener members1480, different implants and/or different facet reinforcement devices1400 may be used at different locations.

FIG. 85 shows another embodiment of a facet reinforcement device 1500.In the illustrated arrangement, the facet reinforcement device 1500 hasan inferior end 1502 and a superior end 1504. The facet reinforcementdevice 1500 has a first securing portion 1530 toward the inferior end1502 and a second securing portion 1540 toward the superior end 1504.The first securing portion 1530 and second securing portion 1540 can beconnected to each other by a central portion 1510.

The first securing portion 1530 can be configured for placement on anouter facet surface of a facet. The first securing portion 1530 caninclude a lumen 1506 surrounded by a luminal surface 1511. The lumen1506 and the luminal surface 1511 can be substantially circular(cylindrical) as shown in the illustrated embodiment. The lumen 1506 canhave other cross-sectional shapes including, but not limited to,circular (cylindrical), hexagonal, rectangular (cuboid), square,elliptical, and/or have a combination of curved, flat surfaces and/orpartial shapes. The lumen 1506 and the luminal surface 1511 can beshaped based on a shape of a fastener member 1580 (e.g., having a shapecomplimentary or similar to the outer shape of the portion of thefastener member 1580 extending there-through). The lumen 1506 and theluminal surface 1511 may conform to the shape of an insertion tool. Thelumen 1506 and the luminal surface 1511 can include a substantiallysmooth inner surface to allow the fastener member 1580 to easily passthrough. In other embodiments, the lumen 1506 and the luminal surface1511 can include a threaded surface to allow the fastener member tothread into the lumen 1506.

The first securing portion 1530 can include one (as illustrated), two,three or a plurality of lumens 1506. The one or more lumens 1506 canhave the same shape or different shape. The first securing portion 1530may include one row of lumen 1506, for example, the lumens 1506 can bealigned along an axis. In other arrangements, the first securing portion1530 may include multiple rows of lumens 1506. The first securingportion 1530 may include lumens 1506 arranged in a random order ororientation. As will be described below, the one or more lumens 1506 canbe configured to accept one or more fastener members 1580 and/or one ormore fasteners 1590.

The second securing portion 1540 can be configured for placement on avertebral structure. The vertebral structure can be remote or distancedfrom the outer facet surface of a facet. For example, in onearrangement, the second securing portion 1540 can be configured forplacement on an outer surface or base of the spinous process 1570; atranslaminar position, and/or for placement on an outer surface of thelamina (e.g., base of spinous process).

The second securing portion 1540 can include a lumen 1508 surrounded bya luminal surface 1521. The lumen 1508 and the luminal surface 1521 canbe circular (cylindrical). The lumen 1508 can have other cross-sectionalshapes including, but not limited to, hexagonal, rectangular (cuboid),square, elliptical, and/or have a combination of curved, flat surfacesand/or partial shapes. The lumen 1508 can be shaped based on a shape ofthe fastener member 1580 and/or the fastener 1590. The lumen 1508 andthe luminal surface 1521 may be circular, hexagonal, rectangular(cuboid), square, elliptical, and/or have a combination of curved, flatsurfaces and/or partial shapes. The lumen 1508 and the luminal surface1521 may conform to the shape of an insertion tool. The lumen 1508 andthe luminal surface 1521 can include a substantially smooth surface toallow the fastener member 1580 and/or the fastener 1590 to easily passthrough, or the lumen 1508 can include a threaded surface to allow thefastener member 1580 and/or the fastener 1590 to thread into the lumen1508.

The second securing portion 1540 can include one, two (as illustrated),three or a plurality of lumens 1508. Additional lumens 1508 may increasefixation security and reduce torsional forces.

The one or more lumens 1508 can have the same shape or different shape.The two lumens 1508 depicted in FIG. 85 have substantially the sameshape. The second securing portion 1540 may include one row of lumens1508, for example, the lumens 1508 can be aligned along an axis. The rowof lumens 1508 may be aligned along a longitudinal axis of the secondsecuring portion 1540. The second securing portion 1540 may includemultiple rows of lumens 1508. The second securing portion 1540 mayinclude lumens 1508 arranged in a random order or orientation. The oneor more lumens 1508 can be configured to accept one or more fastenermembers 1580 and/or one or more fasteners 1590. The one or more lumens1508 can be oriented in order to facilitate placement of the fastenermembers 1580 and/or the fasteners 1590. The fastener 1590 may be placedin a translaminar position. The fastener 1590 may be placed in thespinous process, or the base of the spinous process. The fastener 1590may be placed across the spinous process of a vertebra.

At least one surface of the facet reinforcement device 1500 may have afeature to mechanically interfit with an insertion tool (not shown),including grooves and/or protrusions configured to mate with acorresponding groove and/or protrusion of the insertion tool. At leastone surface of the facet reinforcement device 1500 can have a feature(e.g., a recess or groove) to mechanically interfit with the fastenermember 1580 and/or fastener 1590. The feature to mechanically interfitwith the fastener member 1580 and/or fastener 1590 member may increasestability of the system and resistance to migration of components of thesystem.

The diameter of the first securing portion 1530 may be in the range of 2mm-20 mm or the diameter may be in the range of 4 mm-15 mm. The diameterof the lumen 1506 may be in the range of 0.5 mm-10 mm or in the range of1-7 mm. The diameter of the lumen 1508 may be in the range of 0.5 mm-10mm or 1-7 mm.

In some embodiments, at least a portion of one surface of the facetreinforcement device 1500 has a roughened surface and/or a poroussurface, as described above with respect to FIG. 82. The roughenedsurface can comprise at least one projection 1516. In one embodiment,the projection 1516 can comprise at least one spike, barb, wedge, orhook projecting from one surface of the facet reinforcement device 1500.The first securing portion 1530, the second securing portion 1540, thecentral portion 1510, and/or any combination of these portions mayinclude a roughened surface and/or a porous surface. In some embodiment,an adhesive or sealant, such as a cyanoacrylate, polymethylmethacrylate,or other adhesive known in the art, is used to bond one surface of thefacet reinforcement device 1500 to a bone or tissue surface. In someembodiments, at least a portion of one surface of the facetreinforcement device 1500 may be curved or malleable. The portion of onesurface of the facet reinforcement device 1500 may be shaped to conformto a shape of an anatomic structure, such as a facet or spinous process.

As shown the first securing portion 1530 and the second securing portion1540 may lie on different planes as shown in FIG. 85. The first securingportion 1530 can lie on a plane P1, as shown in FIG. 85. The firstsecuring portion 1530 can include the lumen 1506. The lumen 1506 has acentral, longitudinal axis, Axis 1, extending through the lumen 1506.The plane P1 can lie perpendicular to the Axis 1 of the lumen 1506 ofthe first securing portion 1530. The plane P1 can lie adjacent to adistal surface 1531 of the first securing portion 1530. The plane P1 canlie adjacent to a surface of the first securing portion 1530 configuredto engage a bone or tissue.

The second securing portion 1540 can lie on a plane P2. The secondsecuring portion 1540 can include at least one lumen 1508. The lumen1508 has a central, longitudinal axis, Axis 2, extending through thelumen 1508. The plane P2 can lie parallel to the Axis 2 of the lumen1508 of the second securing portion 1540. The plane P2 can lie adjacentto a distal surface 1541 of the second securing portion 1540. The planeP2 can lie adjacent to a surface of the second securing portion 1540configured to engage a bone or tissue.

The plane P1 may be angled relative to the plane P2 to form an angle A(see FIG. 85) between the plane P1 and the plane P2. The angle A may bebetween 30-150 degrees. The angle A may be 60-105 degrees in onearrangement. The Axis 1 and the Axis 2 may not be parallel in sucharrangements. In one embodiment, the Axis 1 and the Axis 2 may beperpendicular. In other embodiments, the Axis 1 may be angled relativeto the Axis 2.

In certain arrangements, the first securing portion 1530 may be offsetin multiple dimensions from the second securing portion 1540. The firstsecuring portion 1530 may be offset along a longitudinal axis of thefacet replacement device 1500 from the second securing portion 1540. Thelongitudinal axis of the first securing portion 1530 may be offset,angled, or otherwise not aligned with the longitudinal axis of thesecond securing portion 1540.

For example, as illustrated in FIG. 86, the second securing portion 1540may lie medial and/or posterior to the first securing portion 1530. Thesecond securing portion 1540 may lie superior to the first securingportion 1530. Proximal or posterior, as referred to here, refers to thepart of the vertebra or the facet reinforcement device that isconfigured to be implanted in a vertebra toward the tip of the spinousprocess. Distal and anterior refer to the part of the vertebra or thefacet reinforcement device that is configured to be implanted in avertebra toward the vertebral body. Medial refers to toward the midline(center of spinous process), lateral refers to a direction away from themidline (toward the tip of the transverse processes). Superior refers toa direction toward the head, or to a part of the facet reinforcementdevice that configured to face toward the head on placement, andinferior to a structure or part of the facet reinforcement device whichfaces or is positioned toward the feet. The central portion 1510 may bebent and/or twisted to provide the offset and/or angulation of the firstsecuring portion 1530 relative to the second securing portion 1540.

FIGS. 86-87 show perspective views of a portion of the vertebral columnduring a method for fusing adjacent vertebrae using the facetreinforcement device 1500. The method may include using an implantdeployed to restore the space between facets of a superior articularprocess of a first vertebra and an inferior articular process of anadjacent vertebra.

In one method of use, a drill or other device can be used to form alumen in superior articular process SAP2A of vertebra V2 and inferiorarticular process IAP1A of vertebra V1. A portion of the surface of thefacet of SAP2A and a portion of the surface of the facet of IAP1A can beprepared for fusion. Specifically, a portion of the surface of the facetcan be ground, scored, roughened, sanded, etc., such that the surface ofthe facet can better adhere to any substances to aid in fusion and/orotherwise fuse more readily to the implant if used.

FIG. 86 illustrates the facet reinforcement device 1500 placed on anouter surface of the superior vertebra V1. The first securing portion1530 is placed on outer, posterior facing surface of the left inferiorarticular process IAP1A of the superior vertebra V1. The second securingportion 1540 is placed on outer surface of the spinous process, near thebase of the spinous process of V1.

In one method of use, a lumen is formed in the articular process. Thefacet reinforcement device 1500 can be placed after a lumen is formed inthe articular process. The facet reinforcement device 1500 can be placedprior to forming a lumen in the articular process. In this method, thefacet reinforcement device 1500 may serve as a guide for drilling thelumen. The facet reinforcement device 1500 can be placed afterpreparation for fusion. The facet reinforcement device 1500 can beplaced before preparation for fusion. An insertion tool may remain onthe facet reinforcement device 1500 during the steps of forming thelumen and/or during the step of preparing for fusion.

As shown in FIG. 87, a facet reinforcement device 1500 and a fastenermember 1580 can be used to fuse a vertebra V1 and vertebra V2 via theinferior articular process IAP1A of vertebra V1 and the superiorarticular process SAP2A of vertebra V2. In some embodiments, at leastone implant is used with the fastener member 1580 to fuse a vertebra V1and vertebra V2. FIG. 87 depicts fusing the inferior articular processIAP1A of vertebra V1 and the superior articular process SAP2A ofvertebra V2. However, the inferior articular process IAP1B of vertebraV1 can be fused to the superior articular process SAP2B of vertebra V2.

The fastener member 1580 can be secured. Securing the fastener member1580 can be based on the type of fastener member used. By way ofexample, securing a fastener member 1580 having the characteristics ofthe fastener member depicted in FIGS. 49-51, can include the followingsteps: inserting the proximal end portion of the fastener member 1580into a fastening mechanism 1584; the fastener mechanism located at adistal end portion of the fastener member 1580; securing an end of thefastener member 1580 to the opposite end of the fastener member 1580;securing the proximal end portion of the fastener member 1580 to thedistal end portion of the fastener member 1580; and/or advancing theproximal end portion of the fastener member 1580 through the fasteningmechanism 1584. In other embodiments, fastener member 1580 can besecured by tying a first portion the fastener member to a second portionof the fastener member, by forming a knot in a first end and second end;by screwing the fastener member into a threaded central lumen, bythreading a fastener onto a threaded end of a fastener member disposedthrough a threaded central lumen, by include at the end of the fastenermember, and/or combinations of above. The fastener member 1580 can besecured in order to retain the facet reinforcement device 1500. Thefacet reinforcement device 1500 is retained within a loop or otherdefined segment of the fastener member 1580. The reinforcement device1500 can remain freely movable along a portion of the defined segmentafter the fastener member 1580 is secured. In some embodiments, thereinforcement device 1500 is immobile or otherwise secured along aportion of the defined segment after the fastener member 1580 issecured. The fastener member 1580 can be secured in order to retain thefirst securing portion 1530.

A lumen is formed in the spinous process. The facet reinforcement device1500 can be placed after a lumen is formed in the spinous process. Thefacet reinforcement device 1500 can be placed prior to forming a lumenin the spinous process. In this method, the facet reinforcement device1500 may serve as a guide for drilling the lumen. The second securingportion 1540 can be secured to V1 using fastener member 1580 and/orother fastener 1590. The fastener 1590 may be a screw, a bolt, a dualheaded screw, a pedicle screw, a transpedicular screw, a post, a plug, atether, artificial ligament, a rod or any other device of securing aplate to bone, which would be known to one skilled in the art. Thefasteners 1590 may pass translaminally or through the base of thespinous process 1570. In some embodiments, the fastener 1590 is threadedand the lumen 1508 is threaded. The corresponding threading betweenlumen 1508 and fastener 1590 may facilitate the securing and/or lockingof the fastener 1590 to the facet reinforcement device 1500. FIG. 86depicts two lumens 1508 in the second securing portion 1540. Thefasteners 1590 associated with the lumens 1508 may be the same ordifferent, or a combination of similar and different fasteners for threeor more lumens 1508.

FIG. 87 illustrates the assembled system, including the facetreinforcement device 1500 and the fastener member 1580. The assembledsystem is implanted on the left facet joint between a superior vertebraV1 and an inferior vertebra V2. The left facet joint may be compressedby the assembled system, thereby bringing the two facet surfaces inclose apposition. This compression is in contrasts with the unsecuredright facet joint.

FIG. 88 shows an embodiment of a facet reinforcement device 1600. Thefacet reinforcement device 1600 has similar features to the facetreinforcement device 1500, described herein. The facet reinforcementdevice 1600 includes a first securing portion 1630 toward an inferiorend 1602 and a second securing portion 1640 toward a superior end 1604.A central portion 1610 connects the first securing portion 1630 and thesecond securing portion 1640. The first securing portion 1630 caninclude at least one lumen 1606 surrounded by a luminal surface 1611.The first securing portion 1630 can be configured for placement on anouter facet surface of a facet. In some embodiments, at least a portionof one surface of the facet reinforcement device 1600 has a roughenedsurface and/or a porous surface, which may include at least oneprojection 1616.

The second securing portion 1640 can be configured for placement on avertebral structure. The vertebral structure can be remote from theouter facet surface of a facet. The second securing portion 1640 can beconfigured for placement on an outer surface of the spinous process1670.

The second securing portion 1640 can include at least one lumen 1608surrounded by a luminal surface 1621. The second securing portion 1640can include two lumens 1608. The two lumens 1608 may be in a differentconfiguration than lumens 1508, shown in FIG. 85. For example, the twolumens 1608 are oriented vertically along the spinous process in thesecond securing portion 1640. The two lumens 1508 are orientedhorizontally along the base of the spinous process in the secondsecuring portion 1540. The orientation of the two lumens 1608 of thefacet reinforcement device 1600 is generally perpendicular to the lumens1508 of the facet reinforcement device 1500. The orientation shown inFIG. 89 may be advantageous in countering forces on the facetreinforcement device 1600. The orientation shown in FIG. 89 may permitincreased visualization of posterior vertebral structures such as the V1lamina. The orientation of the lumens 1608 permits placement offasteners 1690A across the spinous process 1670.

The first securing portion 1630 and the second securing portion 1640 maylie on different planes. The first securing portion 1630 lies on a planeP3, as shown in FIG. 88. The lumen 1606 has a central, longitudinalaxis, Axis 1, extending through the lumen 1606. The plane P3 liesperpendicular to the Axis 1 of the lumen 1606 of the first securingportion 1630. The plane P3 can lie adjacent to a distal surface 1631 ofthe first securing portion 1630.

The second securing portion 1640 lies on a plane P4. The second securingportion 1640 can include at least one lumen 1608. The lumen 1608 has acentral, longitudinal axis, Axis 2, extending through the lumen 1608.The plane P4 lies parallel to the Axis 2 of the lumen 1608 of the secondsecuring portion 1640. The plane P4 can lie adjacent to a distal surface1641 of the second securing portion 1640. The plane P3 may be angledrelative to the plane P4. An angle A may be formed between the plane P3and the plane P4. The angle A may be between 30-150 degrees. The angle Amay be 60-105 degrees. The first securing portion 1630 may be offset inmultiple dimensions from the second securing portion 1640.

FIGS. 89-91 show perspective views of a portion of the vertebral columnduring a method for fusing adjacent vertebrae using a facetreinforcement device 1600 and a facet reinforcement device 1600A. Theimplantation of the facet reinforcement devices 1600, 1600A can besubstantially similar to the implantation of the facet reinforcementdevice 1500.

FIG. 90 illustrates the facet reinforcement devices 1600 and 1600Aplaced on an outer surface of the superior vertebra V1. A first securingportion 1630 is placed on outer, posterior facing surface of the leftinferior articular process IAP1A of the superior vertebra V1. A secondsecuring portion 1640 is placed on outer surface of the spinous process1670. A first securing portion 1630A is placed on outer, posteriorfacing surface of the right inferior articular process IAP1B of thesuperior vertebra V1. A second securing portion 1640A is placed on outersurface of the spinous process 1670.

The second securing portion 1640 can include two lumens 1608. The twolumens 1608 are oriented vertically along the spinous process in thesecond securing portion 1640. The second securing portion 1640A caninclude two lumens 1608A. The two lumens 1608A are oriented verticallyalong the spinous process in the second securing portion 1640A. Theorientation of the lumens 1608, 1608A permits placement of fasteners1690A across the spinous process 1670.

A lumen can be formed in superior articular process SAP2A of vertebra V2and inferior articular process IAP1A of vertebra V1. A lumen can beformed in superior articular process SAP2B of vertebra V2 and inferiorarticular process IAP1B of vertebra V1. A fastener member 1680 and afastener member 1680A can be inserted in a manner as described above.The proximal end portion of a fastener member 1680 can be inserted intothe lumen 1606 of the first securing portion 1630, the lumen of inferiorarticular process IAP1A of vertebra V1, and the lumen of superiorarticular process SAP2A of vertebra V2. The proximal end portion of afastener member 1680A can be inserted into a lumen in the first securingportion 1630A, the lumen of inferior articular process IAP1B of vertebraV1, and the lumen of superior articular process SAP2B of vertebra V2. Animplant can be inserted between the superior articular process and theinferior articular process.

The fastener members 1680, 1680A can have the characteristics of thefastener member 1580 and can be secured in a similar manner to securingfastener member 1580. The proximal end portion of the fastener member1680, 1680A can be inserted into a fastening mechanism 1684, 1684A. Thefastener mechanism 1684, 1684A can be located at a distal end portion ofthe fastener member 1680, 1680A. As shown in FIG. 90, the facetreinforcement device 1600 and the fastener member 1680 can be used tofuse a vertebra V1 and vertebra V2 via the inferior articular processIAP1A of vertebra V1 and the superior articular process SAP2A ofvertebra V2. The facet reinforcement device 1600A and a fastener member1680A can be used to fuse a vertebra V1 and vertebra V2 via the inferiorarticular process IAP1B of vertebra V1 and the superior articularprocess SAP2B of vertebra V2. The facet reinforcement device 1600 can besubstantially similar to the facet reinforcement device 1600A. The facetreinforcement device 1600 can be a mirror image of the facetreinforcement device 1600A.

A lumen is formed in the spinous process 1670. The second securingportions 1640, 1640A can be secured to V1 using the fastener members1680, the fastener 1690, and/or the fastener 1690A. The fastener members1680 and the fastener 1690 can be inserted in a manner as describe abovewith respect to fastener members 1580 and the fastener 1590. Thefastener 1690 may be a screw, a bolt, a dual headed screw, a pediclescrew, a transpedicular screw, a post, a plug, a tether, artificialligament, a rod or any other means of securing a plate to bone, whichwould be known to one skilled in the art. In some embodiments, thefastener 1690 is threaded and the lumen 1608 is threaded. Thecorresponding threading between the lumen 1608 and the fastener 1690 mayfacilitate the securing and/or locking of the fastener 1690 to the facetreinforcement device 1600. FIG. 89 depicts two lumens 1608 in the secondsecuring portion 1640. The fasteners 1690 associated with the lumens1608 may be the same or different, or a combination of similar anddifferent fasteners for three or more lumens 1608.

The fastener 1690A may pass translaminally or through the spinousprocess 1670. The fastener 1690A is located between the lumen 1608 andthe lumen 1608A. The fastener 1690A is located between the secondsecuring portion 1640 and the second securing portion 1640A. Referringto FIGS. 90 and 91, the fastener 1690A is illustrated with head 1694,shaft 1696, and nut 1692. The shaft 1696 may be threaded or smooth. Thefastener 1690A can take the form of a screw, a bolt, a dual headedscrew, a pedicle screw, a transpedicular screw, a post, a plug, atether, artificial ligament, a rod or any other form known in the art.Additional security may be provided by securing the two facetreinforcement devices 1600, 1600A together through the spinous process.

FIGS. 89-91 illustrate the assembled system, including the facetreinforcement device 1600 and 1600A. FIG. 91 illustrates the system,viewed from superior to V1. The fasteners 1690A may be seen passingthrough lumen 1608 in facet reinforcement device 1600, through spinousprocess 1670 and through lumen 1608A in facet reinforcement device 1600Ain FIG. 90.

The assembled system is implanted on the left facet joint and the rightfacet joint between a superior vertebra V1 and an inferior vertebra V2.The facet joints may be compressed by the assembled system, therebybringing the two facet surfaces in close apposition. The implantation ofthe second facet reinforcement device 1600A and the second fastenermember 1680A may improve stabilization.

The facet reinforcement device 1400, 1500, 1600, 1600A and fasteners1580, 1590, 1680, 1690, 1690A may be made of any of a variety ofmaterials known in the art, including but not limited to a polymer suchas polyetheretherketone (PEEK), polyetherketoneketone (PEKK),polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such aszirconia, alumina, or silicon nitride; a metal such as titanium,titanium alloy, cobalt chromium or stainless steel; or any combinationof the above materials. The facet reinforcement device 1400, 1500, 1600,1600A may be made of multiple materials in combination. For example, theablumenal surface 1404 can comprise a polymer, such as PEEK orpolyethylene, and the luminal surface 1410 can comprise a metal orceramic. For example, the proximal surface 1402 can comprise a polymerand the distal surface 1406 and/or the projections 1416 can comprise ametal or ceramic. The material of the facet reinforcement device 1400can be the same as the material of the fastener member and/or theimplant. The material of the facet reinforcement device 1400 can bedifferent from the material of the fastener member and/or the implant.

Kits may be provided to facilitate spine fixation procedures. Kits mayinclude one or more facet reinforcement devices, such as any of thosedescribed herein. Different sizes and configurations of facetreinforcement devices may be provided in a single kit. Different kitsmay be available that have different sizes and configurations of facetreinforcement devices. Kits may include one or more fastener members,such as any of those described herein. The kits may include one or morefasteners, such as any of those described herein. These fasteners may bescrews, bolts and nuts, tethers, plugs, posts or other configurations offastener that would be known to one of skill in the art. Kits mayinclude one or more facet implants, such as any of those describedherein.

Kits may include drills or drill bits for creating lumens in thearticular processes of a facet joint. The kits may include drills ordrill bits for creating lumens in the spinous process. Kits may includedrills or drill bits for creating a fastener lumen in bone. The kits mayinclude tools for preparing the facet joint surface. Kits may includeone or more tools for implantation.

Methods of use may include any of the following steps. Method steps mayinclude: using an implant deployed to restore the space between facetsof a superior articular process of a first vertebra and an inferiorarticular process of an adjacent vertebra; forming a lumen in a superiorarticular process of a vertebra; forming a lumen in a inferior articularprocess of a vertebra; forming a lumen in a second superior articularprocess of a vertebra; forming a lumen in a second inferior articularprocess of a vertebra; and/or preparing the surface of the facet forfusion.

Method steps may include: placing a facet reinforcement device on anouter surface of the superior vertebra; placing the first securingportion on the inferior articular process; and/or placing secondsecuring portion on outer surface of the spinous process.

Method steps may include: fusing the vertebra with a fastener member;positioning the fastener member in a first securing portion; insertingthe fastener member into a lumen of a first securing portion; insertingthe fastener member into the lumen of an inferior articular process of avertebra; advancing the fastener member; and/or inserting the fastenermember into the lumen of a superior articular process of a vertebra.

Method steps may include: securing the fastener member; inserting an endof the fastener member into a fastening mechanism; advancing thefastener member through the fastening mechanism; retaining the facetreinforcement device; and/or retaining the first securing portion.

Method steps may include: forming a lumen in the spinous process;positioning a fastener member in a second securing portion; positioninga fastener in a second securing portion; positioning a fastener in asecond securing portion that passes tranlaminally; and/or positioning afastener between the second securing portion of a first facetreinforcement device and the second securing portion of a second facetreinforcement device.

Method steps may include: preparing a facet joint; positioning a facetreinforcement device, placing a fastener member through a facetreinforcement device; placing a fastener member through a firstarticular process of a facet joint; placing a fastener member through asecond articular process of the facet joint; and/or securing thefastener member over the facet reinforcement device. The positioning ofthe facet reinforcement device may be performed prior to preparing thefacet joint or after preparing the facet joint. The step of preparingthe facet joint may involve drilling a lumen through both articularprocesses of the facet joint. The step of preparing the facet joint mayinvolve roughening up, drilling, burring, or otherwise preparing thearticular surfaces of the facet joint.

The method may include passing the fastener member through an aperturein an implant. The method may include any of the following steps fromthe following order: placing a fastener member through the facetreinforcement device; then placing the fastener member through a firstarticular process of a facet joint; then placing the fastener memberthrough an implant; then placing the fastener member through a secondarticular process of the facet joint.

The method may include securing the fastener member. The method mayinclude passing an end of the fastener member through a fasteningmechanism; inserting the proximal end portion of the fastener member1480 into a fastening mechanism 1484; the fastener mechanism located ata distal end portion of the fastener member 1480; securing an end of thefastener member 1480 to the opposite end of the fastener member 1480;securing the proximal end portion of the fastener member 1480 to thedistal end portion of the fastener member 1480; and/or advancing theproximal end portion of the fastener member 1480 through the fasteningmechanism 1484. The method may include tying a first portion thefastener member to a second portion of the fastener member; forming aknot in a first end and second end; screwing the fastener member into athreaded central lumen; threading a fastener onto a threaded end of afastener member disposed through a threaded central lumen; and/orincluding enlarged portions at the end of the fastener member. Themethod may include using the fastener member to secure the facetreinforcement device; and/or using the fastener member to secure thefacet first securing portion.

The method may include securing the fastener. The method may includepassing an end of the fastener through the second securing portion;passing an end of the fastener through the second securing portion of afirst facet reinforcement device; and/or passing an end of the fastenerthrough the second securing portion of a second facet reinforcementdevice. The step of positioning the facet reinforcement device may befollowed by the step of using a fastener. The method may include using afastener to secure the facet reinforcement device to a vertebralstructure. This vertebral structure may be a spinous process, the baseof a spinous process, or other posterior structure. The step of using afastener may include placing one or more fasteners.

The method may include repeating steps to place a second facetreinforcement device at the contralateral facet joint. The method mayinclude repeating steps to place a second facet reinforcement device atanother facet joint. The method may include repeating steps to place asecond facet reinforcement device at another vertebral level. The methodmay include using a fastener to secure the facet reinforcement device toa vertebral structure. The method may include by placing one or morefasteners through a lumen in the first facet reinforcement device andthrough a lumen in the second facet reinforcement device. The fastenermay be placed through a vertebral structure. The fastener may be placedthrough a spinous process. The fastener may be secured with a nut orother securing element. The fastener may be threaded into a lumen in thefirst facet reinforcement device and/or a lumen in the second facetreinforcement device.

In the above embodiments, it should be understood that fastener membersimilar to any of those described above, for example, at 72, 280, 380,480, 580, 680, 780, and 880, may be used with any of the embodiments ofthe facet reinforcement device described herein. Furthermore, the facetreinforcement devices may be used with various of the facet implantsdescribed herein, such as those with a wire or cable retaining device.Though the facet reinforcement devices are primarily described inrelation to reinforcing the inferior articular process, it is to beunderstood that embodiments may also be used to reinforce the superiorarticular process. For example, for use on a surface of a superiorfacet, embodiments of a facet reinforcement device similar to 1500 maybe shaped and sized such that the second securing portion 1540 meets thevertebra. The facet reinforcement device 1500 could permit placement ofone or more fasteners 1590 through, for example, the pedicle or into thevertebral body.

Similarly, through the illustrations of the facet reinforcement deviceshow the facet reinforcement device applied to lumbar vertebrae, it willbe understood that multiple sizes and shapes may be provided adapted forplacement on facet surfaces in the cervical or thoracic region.

The terms “generally” “approximately”, “about”, and “substantially” asused herein represent an amount or characteristic close to the statedamount or characteristic that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“generally” “about”, and “substantially” may refer to an amount that iswithin less than 10% of, within less than 5% of, within less than 1% of,within less than 0.1% of, and within less than 0.01% of the statedamount or characteristic.

The term “up to about” as used herein has its ordinary meaning as knownto those skilled in the art and may include 0 wt. %, minimum or tracewt. %, the given wt. %, and all wt. % in between.

Although the present invention has been described in relation to variousexemplary embodiments, various additional embodiments and alterations tothe described embodiments are contemplated within the scope of theinvention. Thus, no part of the foregoing description should beinterpreted to limit the scope of the invention as set forth in thefollowing claims. For all of the embodiments described above, the stepsof the methods need not be performed sequentially.

1-14. (canceled)
 15. A method of treating a spine, comprising: passing aproximal end of a fastener member through a lumen of a facetreinforcement device; passing the proximal end of the fastener memberthrough a first articular process of a facet joint; passing the proximalend of the fastener member through a second articular process of thefacet joint; and passing the proximal end of the fastener member to theother end through a fastener of the fastener member, thereby retainingthe facet reinforcement device.
 16. The method of claim 15, furthercomprising: securing the facet reinforcement device to a vertebra with afastener.
 17. The method of claim 16, wherein securing the facetreinforcement device to a vertebra with a fastener comprises securingthe facet reinforcement device to a spinous process, the base of aspinous process, or the lamina of a vertebra.
 18. The method of claim15, further comprising: inserting an implant into the facet joint,wherein the implant comprises an interface configured to receive theproximal end of the fastener member; and passing the proximal end of thefastener member through the interface of the implant.
 19. The method ofclaim 15, further comprising: preparing a second facet joint; passing aproximal end of a second fastener member through a lumen of a secondfacet reinforcement device; passing the proximal end of the secondfastener member through a first articular process of a second facetjoint; passing the proximal end of the second fastener member through asecond articular process of the second facet joint; and passing theproximal end of the second fastener member through a fastener of thesecond fastener member, thereby retaining the second facet reinforcementdevice.
 20. The method of claim 19, further comprising: inserting asecond implant into the second facet joint, wherein the second implantcomprises an interface configured to receive the second fastener member;and passing the proximal end of the second fastener member through theinterface of the second implant.
 21. A method of treating bone portions,the method comprising: disposing a proximal portion of a flexiblefastening band through a lumen of a facet reinforcement device, whereina distal portion of the flexible fastening band comprises a fastener;disposing the proximal portion of the flexible fastening band intocontact with a first bone portion; disposing the proximal portion of theflexible fastening band into contact with a second bone portion;inserting the proximal portion of the flexible fastening band into thefastener to form a loop, after disposing the proximal portion of theflexible fastening band into contact with the lumen, the first boneportion, and the second bone portion; and advancing the proximal portionof the flexible fastening band through the fastener to tighten the loop.22. The method of claim 21, further comprising disposing an implantbetween the first bone portion and the second bone portion.
 23. Themethod of claim 22, further comprising disposing the implant between thefirst bone portion and the second bone portion before disposing theproximal portion of the flexible fastening band into contact with thesecond bone portion.
 24. The method of claim 22, further comprisingdisposing the proximal portion of the flexible fastening band throughthe implant when the implant is between the first bone portion and thesecond bone portion.
 25. The method of claim 21, further comprisingforming a lumen in the first bone portion, wherein disposing theproximal portion of the flexible fastening band into contact with thefirst bone portion comprises disposing the proximal portion of theflexible fastening band through the lumen of the first bone portion. 26.The method of claim 25, further comprising forming a lumen in the secondbone portion, wherein disposing the proximal portion of the flexiblefastening band into contact with the second bone portion comprisesdisposing the proximal portion of the flexible fastening band throughthe lumen of the second bone portion.
 27. The method of claim 21,further comprising removing an excess portion of the proximal portionafter advancing the proximal portion of the flexible fastening bandthrough the fastener.
 28. The method of claim 21, wherein the first boneportion is an articular process of a first vertebra and the second boneportion is an articular process of a second vertebra.
 29. The method ofclaim 21, wherein advancing the proximal portion of the flexiblefastening band comprises advancing the proximal portion over a ratchetin the fastener.
 30. The method of claim 29, wherein advancing theproximal portion of the flexible fastening band comprises advancinggears of a gear rack on the flexible fastening band over the ratchet inthe fastener.
 31. The method of claim 21, further comprising securingthe facet reinforcement device to a third bone portion with a fastener.32. The method of claim 31, wherein securing the facet reinforcementdevice to the third bone portion with the fastener comprises securingthe facet reinforcement device to a spinous process
 33. The method ofclaim 31, wherein securing the facet reinforcement device to the thirdbone portion with the fastener comprises securing the facetreinforcement device to the lamina of a vertebra.
 34. The method ofclaim 21, wherein the flexible fastening band comprises a reinforcementportion.
 35. A method of treating bone portions, the method comprising:disposing a proximal portion of a flexible fastening band into contactwith a first bone portion, wherein the flexible fastening band comprisesa fastener; disposing the proximal portion of the flexible fasteningband into contact with a second bone portion; disposing the proximalportion of the flexible fastening band through a lumen of a facetreinforcement device; inserting the proximal portion of the flexiblefastening band into the fastener to form a loop, after disposing theproximal portion of the flexible fastening band into contact with thelumen, the first bone portion, and the second bone portion; andadvancing the proximal portion of the flexible fastening band throughthe fastener.